The regulatory affairs sector is concerned with ensuring that companies meet all the legal requirements regarding their products. Professionals working in regulatory affairs jobs are vital in industries like pharmaceuticals, healthcare, and food production. They handle 204 Regulatory Affairs jobs in the United Kingdom
Regulatory Affairs Officer
Reading, South East
Sanofi Group
Posted 3 days ago
Job Viewed
Job Description
_About the job_
**_Job Purpose:_**
+ To obtain, manage and maintain product Marketing Authorisations in line with business goals and legal requirements. To conduct associated regulatory activities for the specified markets under the guidance and supervision of line management, and to contribute to the implementation and leading of projects.We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
**Main responsibilities:**
+ Co-ordinates, prepares, submits and follows up registration applications to the UK and /or Irish regulatory authorities, expeditiously and to high standards, to ensure that marketing authorisations are obtained and maintained in line with the company's plans and goals.
+ Prepares and submits responses to enquiries and deficiencies noted by regulatory authorities in connection with applications filed, under supervision, to facilitate the earliest possible approval.
+ Prepares and reviews labelling, package leaflets and summaries of product characteristics etc. to ensure compliance with current legislation and registered particulars, and takes action, as agreed with supervisor, to secure regulatory approval where necessary.
+ Supports the launch of new products and life cycle management of the existing portfolio.
+ In order to achieve success, it is essential that the Regulatory Officer:
+ Ensures that all data supplied to the regulatory authorities are of the highest quality possible in terms of both content and presentation, whilst meeting agreed deadlines.
+ Works proactively with members of the Global Business Units and other Global functions to ensure project needs are met compliantly within agreed timelines
+ Assists management in providing strategic input into development of registration strategies and operating planning processes for commercialisation of products, both locally and in conjunction with GRA.
+ Contributes to the effective running of departmental and cross functional project teams
+ Supports activities to obtain, manage and maintain product Marketing Authorisations in line with business goals and legal requirements. Conducts associated regulatory activities for the specified markets under the guidance and supervision of line management, and contributes to the implementation and leading of projects.
+ Provides regulatory input, with support, to commercial strategic and operating planning process.
**_About you_**
+ At least 1 year experience working in Regulatory Affairs, preferably up to 2 years.
+ An understanding of lifecycle maintenance for pharmaceutical products, particularly variations.
+ Proven project management skills.
+ Biologicals and/or Vaccines experience desirable.
+ Life sciences or chemistry degree or equivalent professional qualification or proven relevant experience within the regulatory environment.
+ Proven familiarity with the pharmaceutical research and development process with ability to integrate scientific information from a variety of disciplines.
+ Ability to work across a variety of therapeutic areas with new and/or established medicines with the capability to represent Regulatory at brand meetings, with support from management.
+ An awareness of EU regulatory procedures for marketing authorisations and submission to regulatory authorities.
+ An awareness of lifecycle maintenance for pharmaceutical products, including variations and renewals.
+ An awareness of ABPI and IPHA code, promotional and non-promotional materials and PI.
+ Awareness of product quality and Good Manufacturing Practice (GMP) requirements.
+ An understanding of CMC changes and the ability to identify changes to registered details.
+ An understanding of the Common Technical Document (CTD) and pharmaceutical dossier structure.
+ Administratively well organised, demonstrating attention to detail, strong written and oral communication skills. Able to communicate effectively and efficiently with other functional departments in the business.
**_Why choose us?_**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
+ Join us in shaping the future of respiratory care and making a difference in the lives of patients across the NHS.
+ If you have a disability and require adjustments for the interview process, please email us at We are dedicated to ensuring an inclusive and supportive experience for all applicants.
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
**_Job Purpose:_**
+ To obtain, manage and maintain product Marketing Authorisations in line with business goals and legal requirements. To conduct associated regulatory activities for the specified markets under the guidance and supervision of line management, and to contribute to the implementation and leading of projects.We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
**Main responsibilities:**
+ Co-ordinates, prepares, submits and follows up registration applications to the UK and /or Irish regulatory authorities, expeditiously and to high standards, to ensure that marketing authorisations are obtained and maintained in line with the company's plans and goals.
+ Prepares and submits responses to enquiries and deficiencies noted by regulatory authorities in connection with applications filed, under supervision, to facilitate the earliest possible approval.
+ Prepares and reviews labelling, package leaflets and summaries of product characteristics etc. to ensure compliance with current legislation and registered particulars, and takes action, as agreed with supervisor, to secure regulatory approval where necessary.
+ Supports the launch of new products and life cycle management of the existing portfolio.
+ In order to achieve success, it is essential that the Regulatory Officer:
+ Ensures that all data supplied to the regulatory authorities are of the highest quality possible in terms of both content and presentation, whilst meeting agreed deadlines.
+ Works proactively with members of the Global Business Units and other Global functions to ensure project needs are met compliantly within agreed timelines
+ Assists management in providing strategic input into development of registration strategies and operating planning processes for commercialisation of products, both locally and in conjunction with GRA.
+ Contributes to the effective running of departmental and cross functional project teams
+ Supports activities to obtain, manage and maintain product Marketing Authorisations in line with business goals and legal requirements. Conducts associated regulatory activities for the specified markets under the guidance and supervision of line management, and contributes to the implementation and leading of projects.
+ Provides regulatory input, with support, to commercial strategic and operating planning process.
**_About you_**
+ At least 1 year experience working in Regulatory Affairs, preferably up to 2 years.
+ An understanding of lifecycle maintenance for pharmaceutical products, particularly variations.
+ Proven project management skills.
+ Biologicals and/or Vaccines experience desirable.
+ Life sciences or chemistry degree or equivalent professional qualification or proven relevant experience within the regulatory environment.
+ Proven familiarity with the pharmaceutical research and development process with ability to integrate scientific information from a variety of disciplines.
+ Ability to work across a variety of therapeutic areas with new and/or established medicines with the capability to represent Regulatory at brand meetings, with support from management.
+ An awareness of EU regulatory procedures for marketing authorisations and submission to regulatory authorities.
+ An awareness of lifecycle maintenance for pharmaceutical products, including variations and renewals.
+ An awareness of ABPI and IPHA code, promotional and non-promotional materials and PI.
+ Awareness of product quality and Good Manufacturing Practice (GMP) requirements.
+ An understanding of CMC changes and the ability to identify changes to registered details.
+ An understanding of the Common Technical Document (CTD) and pharmaceutical dossier structure.
+ Administratively well organised, demonstrating attention to detail, strong written and oral communication skills. Able to communicate effectively and efficiently with other functional departments in the business.
**_Why choose us?_**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
+ Join us in shaping the future of respiratory care and making a difference in the lives of patients across the NHS.
+ If you have a disability and require adjustments for the interview process, please email us at We are dedicated to ensuring an inclusive and supportive experience for all applicants.
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
This advertiser has chosen not to accept applicants from your region.
0
Regulatory Affairs Manager
Witney, South East
Abbott
Posted 13 days ago
Job Viewed
Job Description
**Regulatory Affairs Manager**
**Abbott Diabetes Care**
**Witney, Oxfordshire**
**Competitive Salary + Excellent Benefits**
Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems and test strips for use in both home and hospital settings. Our product portfolio includes Freestyle Libre, a recently launched system that is revolutionising how people with diabetes around the world monitor their glucose levels. We are passionate about doing work that improves the quality of people's lives.
We currently have an opportunity for a Regulatory Affairs Manager to join our team, based in Oxfordshire, supporting the significant manufacturing capacity expansion underway at the Witney site plus other Operational and R&D projects.
**Primary Job Function**
You will set the EU Regulatory Strategy that is well-defined and effective. The strategy sets out innovative solutions to Regulatory Approval so that plans can be set out.
You will oversee the Project Management of regulatory projects, integrating with the US and OUS Regulatory organisation, the R&D organisation and other key functional groups.
**Core Job Responsibilities**
+ Ensures maintenance of strong communication and working relationships with the Alameda RA group and other RA teams globally.
+ Ensures maintenance of strong communication and working relationships with the Clinical Affairs organisation, R&D Development groups and US Project Management.
+ Supports the interface and guidance of any external auditors such as FDA and ISO assessors reviewing Technical Files.
+ Provides leadership on Notified Body strategy and regional/global planning of product registration.
+ Responsible for defining the regulatory strategy for product approvals in EU and region.
+ Each new development project (product) requires a regulatory strategy to be created and maintained.
+ Responsible for supporting RA compliance with site EHS policy and procedures.
+ Responsible for maintaining the effectiveness of the Quality System at the site in accordance with Abbott Corporate requirements and applicable regulations.
+ Excellent communication / negotiating skills for discussions with Notified Bodies and Competent Authorities etc.
**Position Accountability / Scope**
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
+ This position must ensure that the products are registered in the countries as appropriate and ensure compliance to QS Regulations, ISO regulations, etc.
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
**Minimum** **Education**
+ Minimum of a Bachelor's degree or equivalent preferably in a Scientific discipline e.g. Chemistry, life Sciences, Biology.
**Minimum** **Experience/Training Required**
+ Minimum of a bachelor's degree is required to ensure that the jobholder has sufficient technical knowledge to effectively and confidently be the Regulatory Affairs Project Mgr in the EMEA region.
+ Knowledge of regulatory requirements for ISO 13485, EMC, MDD (93/42/EEC), IVDD (98/79/EC), MDR 2017/745 & IVDR 2017/756, and FDA Quality Systems Regulations is essential.
+ Experience within a medical or healthcare manufacturing industry in a regulatory role. The position requires an understanding of the needs of the customer and knowledge of regulations and standards affecting IVDs and MDDs, the regulatory bodies and country regulations that govern ADC products to enable the jobholder to interpret and apply regulations and standards to products and processes.
+ You need to have excellent written and oral communication skills necessary to be able to produce succinct reports and documentation and to effectively communicate with other departments, managers and external regulatory organizations.
+ You need to have the depth of Regulatory knowledge to be able to define a Regulatory Strategy that is well defined and effective. Additionally, the depth of experience is required to ensure that innovative solutions to Regulatory Approval paths can be set out.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
**Abbott Diabetes Care**
**Witney, Oxfordshire**
**Competitive Salary + Excellent Benefits**
Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems and test strips for use in both home and hospital settings. Our product portfolio includes Freestyle Libre, a recently launched system that is revolutionising how people with diabetes around the world monitor their glucose levels. We are passionate about doing work that improves the quality of people's lives.
We currently have an opportunity for a Regulatory Affairs Manager to join our team, based in Oxfordshire, supporting the significant manufacturing capacity expansion underway at the Witney site plus other Operational and R&D projects.
**Primary Job Function**
You will set the EU Regulatory Strategy that is well-defined and effective. The strategy sets out innovative solutions to Regulatory Approval so that plans can be set out.
You will oversee the Project Management of regulatory projects, integrating with the US and OUS Regulatory organisation, the R&D organisation and other key functional groups.
**Core Job Responsibilities**
+ Ensures maintenance of strong communication and working relationships with the Alameda RA group and other RA teams globally.
+ Ensures maintenance of strong communication and working relationships with the Clinical Affairs organisation, R&D Development groups and US Project Management.
+ Supports the interface and guidance of any external auditors such as FDA and ISO assessors reviewing Technical Files.
+ Provides leadership on Notified Body strategy and regional/global planning of product registration.
+ Responsible for defining the regulatory strategy for product approvals in EU and region.
+ Each new development project (product) requires a regulatory strategy to be created and maintained.
+ Responsible for supporting RA compliance with site EHS policy and procedures.
+ Responsible for maintaining the effectiveness of the Quality System at the site in accordance with Abbott Corporate requirements and applicable regulations.
+ Excellent communication / negotiating skills for discussions with Notified Bodies and Competent Authorities etc.
**Position Accountability / Scope**
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
+ This position must ensure that the products are registered in the countries as appropriate and ensure compliance to QS Regulations, ISO regulations, etc.
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
**Minimum** **Education**
+ Minimum of a Bachelor's degree or equivalent preferably in a Scientific discipline e.g. Chemistry, life Sciences, Biology.
**Minimum** **Experience/Training Required**
+ Minimum of a bachelor's degree is required to ensure that the jobholder has sufficient technical knowledge to effectively and confidently be the Regulatory Affairs Project Mgr in the EMEA region.
+ Knowledge of regulatory requirements for ISO 13485, EMC, MDD (93/42/EEC), IVDD (98/79/EC), MDR 2017/745 & IVDR 2017/756, and FDA Quality Systems Regulations is essential.
+ Experience within a medical or healthcare manufacturing industry in a regulatory role. The position requires an understanding of the needs of the customer and knowledge of regulations and standards affecting IVDs and MDDs, the regulatory bodies and country regulations that govern ADC products to enable the jobholder to interpret and apply regulations and standards to products and processes.
+ You need to have excellent written and oral communication skills necessary to be able to produce succinct reports and documentation and to effectively communicate with other departments, managers and external regulatory organizations.
+ You need to have the depth of Regulatory knowledge to be able to define a Regulatory Strategy that is well defined and effective. Additionally, the depth of experience is required to ensure that innovative solutions to Regulatory Approval paths can be set out.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
1
Principal, Regulatory Affairs
Newcastle upon Tyne, North East
Danaher Corporation
Posted 13 days ago
Job Viewed
Job Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Leica Biosystems, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Leica Biosystems, we're not just shaping the future of cancer diagnostics - we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact.
Learn about the Danaher Business System ( which makes everything possible.
The Principal, Regulatory Affairs is responsible for developing and executing global regulatory strategies for high-complexity diagnostics including but not limited to IVDs, Companion Diagnostics and digital pathology in the clinical oncology space. This individual will partner with internal teams and external stakeholders to enable successful global commercialization of innovative technologies (including but not limited to IDEs; Performance Study Applications; IVDR TF in EU and 510k and PMA in USA).
This position reports to the Senior Manager, Regulatory Affairs and is part of the Global Regulatory Affairs Team located in Newcastle, UK and will be an on-site role.
In this role, you will have the opportunity to:
+ Serve as the Lead Regulatory Affairs representative on new product development teams for both IVD medical device and RUO products.
+ Develop and execute global regulatory strategies, including FDA 510(k), Pre-Submissions, Health Canada filings, and IVDR Technical File authoring.
+ Provide regulatory guidance on product labelling, marketing materials, and product changes to ensure compliance.
+ Collaborate cross-functionally with global teams and represent Regulatory Affairs on project teams, contributing regulatory intelligence and strategic input.
+ Engage and negotiate with global regulatory agencies to achieve product clearance/approval, while staying current on evolving regulations, guidance, and competitive landscapes.
+ Share regulatory expertise across Leica and Danaher sites, contribute to cross-functional initiatives, and apply Danaher Business System (DBS) tools to drive continuous improvement and measurable results.
The essential requirements of the job include:
+ Bachelor's degree in science or engineering or equivalent experience.
+ Extensive experience with regulatory strategy and submissions for high-complexity diagnostic products in a global market. Experience supporting clinical trials a plus.
+ In-depth working knowledge of FDA, Health Canada and EU regulatory requirements for IVD devices.
+ Proven track record in developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including IVDR, 510k, PMA, and Health Canada submissions.
+ Strong analytical mindset with a continuous drive for regulatory intelligence and minimal supervision needed.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel - list specifics 15% travel, overnight, within territory or locations
It would be a plus if you also possess previous experience in:
+ Applies deep regulatory expertise to the development and global commercialization of complex, high-risk products, balancing short-term problem-solving with long-term strategic outcomes and risk-benefit analysis.
+ Works effectively in matrixed and cross-cultural environments, driving timely decisions, issue resolution, and resource agility while setting high expectations and modeling accountability and integrity.
+ Communicates complex and sensitive information clearly across diverse audiences; builds consensus, demonstrates strong writing and documentation skills, and uses sound judgment to influence and lead through change.
Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Leica Biosystems, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Leica Biosystems, we're not just shaping the future of cancer diagnostics - we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact.
Learn about the Danaher Business System ( which makes everything possible.
The Principal, Regulatory Affairs is responsible for developing and executing global regulatory strategies for high-complexity diagnostics including but not limited to IVDs, Companion Diagnostics and digital pathology in the clinical oncology space. This individual will partner with internal teams and external stakeholders to enable successful global commercialization of innovative technologies (including but not limited to IDEs; Performance Study Applications; IVDR TF in EU and 510k and PMA in USA).
This position reports to the Senior Manager, Regulatory Affairs and is part of the Global Regulatory Affairs Team located in Newcastle, UK and will be an on-site role.
In this role, you will have the opportunity to:
+ Serve as the Lead Regulatory Affairs representative on new product development teams for both IVD medical device and RUO products.
+ Develop and execute global regulatory strategies, including FDA 510(k), Pre-Submissions, Health Canada filings, and IVDR Technical File authoring.
+ Provide regulatory guidance on product labelling, marketing materials, and product changes to ensure compliance.
+ Collaborate cross-functionally with global teams and represent Regulatory Affairs on project teams, contributing regulatory intelligence and strategic input.
+ Engage and negotiate with global regulatory agencies to achieve product clearance/approval, while staying current on evolving regulations, guidance, and competitive landscapes.
+ Share regulatory expertise across Leica and Danaher sites, contribute to cross-functional initiatives, and apply Danaher Business System (DBS) tools to drive continuous improvement and measurable results.
The essential requirements of the job include:
+ Bachelor's degree in science or engineering or equivalent experience.
+ Extensive experience with regulatory strategy and submissions for high-complexity diagnostic products in a global market. Experience supporting clinical trials a plus.
+ In-depth working knowledge of FDA, Health Canada and EU regulatory requirements for IVD devices.
+ Proven track record in developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including IVDR, 510k, PMA, and Health Canada submissions.
+ Strong analytical mindset with a continuous drive for regulatory intelligence and minimal supervision needed.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel - list specifics 15% travel, overnight, within territory or locations
It would be a plus if you also possess previous experience in:
+ Applies deep regulatory expertise to the development and global commercialization of complex, high-risk products, balancing short-term problem-solving with long-term strategic outcomes and risk-benefit analysis.
+ Works effectively in matrixed and cross-cultural environments, driving timely decisions, issue resolution, and resource agility while setting high expectations and modeling accountability and integrity.
+ Communicates complex and sensitive information clearly across diverse audiences; builds consensus, demonstrates strong writing and documentation skills, and uses sound judgment to influence and lead through change.
Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
This advertiser has chosen not to accept applicants from your region.
2
Regulatory Affairs Specialist
Cardiff, Wales
Danaher Corporation
Posted 13 days ago
Job Viewed
Job Description
Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics. The Regulatory Affairs Specialist for Cytiva is responsible for supporting regulatory compliance of Medical Devices placed on the market in EMEA.
This position is part of Medical Regulatory Affairs located in Portsmouth, UK and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
+ Compile all aspects of Technical Documentation for product certification under Regulation (EU) 2017/745 for Medical Devices.
+ Submit Technical Documentation to Notified Bodies for review and approval.
+ Support RA related QMS documentation, Complaints Assessment, Vigilance Reports and Change Controls.
+ Support medical device Regulatory Intelligence process and customer requests.
+ Provide support as required for UK Responsible Person with regard to the requirements set out in the UK MDR 2002 relating to medical devices.
+ Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager.
Who you are:
+ You have a Life Sciences degree or equivalent.
+ You have at least 2-3 years experience in a healthcare / life sciences industry in a regulatory or technical field.
+ Working knowledge of Medical Device regulations (EU MDR, MDCG guidelines, other EMEA), ISO 13485 and ISO 14971.
+ Experience with Quality Management System documentation.
+ Ability to communicate effectively across all departments and functions
+ Good attention to detail.
+ Have excellent English oral and written communication.
+ The ability to present technical, product and regulatory information clearly and concisely.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel required at 10% or less within the EMEA region.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics. The Regulatory Affairs Specialist for Cytiva is responsible for supporting regulatory compliance of Medical Devices placed on the market in EMEA.
This position is part of Medical Regulatory Affairs located in Portsmouth, UK and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
+ Compile all aspects of Technical Documentation for product certification under Regulation (EU) 2017/745 for Medical Devices.
+ Submit Technical Documentation to Notified Bodies for review and approval.
+ Support RA related QMS documentation, Complaints Assessment, Vigilance Reports and Change Controls.
+ Support medical device Regulatory Intelligence process and customer requests.
+ Provide support as required for UK Responsible Person with regard to the requirements set out in the UK MDR 2002 relating to medical devices.
+ Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager.
Who you are:
+ You have a Life Sciences degree or equivalent.
+ You have at least 2-3 years experience in a healthcare / life sciences industry in a regulatory or technical field.
+ Working knowledge of Medical Device regulations (EU MDR, MDCG guidelines, other EMEA), ISO 13485 and ISO 14971.
+ Experience with Quality Management System documentation.
+ Ability to communicate effectively across all departments and functions
+ Good attention to detail.
+ Have excellent English oral and written communication.
+ The ability to present technical, product and regulatory information clearly and concisely.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel required at 10% or less within the EMEA region.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
This advertiser has chosen not to accept applicants from your region.
3
Regulatory Affairs Specialist
Portsmouth, South East
Danaher Corporation
Posted 13 days ago
Job Viewed
Job Description
Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics. The Regulatory Affairs Specialist for Cytiva is responsible for supporting regulatory compliance of Medical Devices placed on the market in EMEA.
This position is part of Medical Regulatory Affairs located in Portsmouth, UK and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
+ Compile all aspects of Technical Documentation for product certification under Regulation (EU) 2017/745 for Medical Devices.
+ Submit Technical Documentation to Notified Bodies for review and approval.
+ Support RA related QMS documentation, Complaints Assessment, Vigilance Reports and Change Controls.
+ Support medical device Regulatory Intelligence process and customer requests.
+ Provide support as required for UK Responsible Person with regard to the requirements set out in the UK MDR 2002 relating to medical devices.
+ Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager.
Who you are:
+ You have a Life Sciences degree or equivalent.
+ You have at least 2-3 years experience in a healthcare / life sciences industry in a regulatory or technical field.
+ Working knowledge of Medical Device regulations (EU MDR, MDCG guidelines, other EMEA), ISO 13485 and ISO 14971.
+ Experience with Quality Management System documentation.
+ Ability to communicate effectively across all departments and functions
+ Good attention to detail.
+ Have excellent English oral and written communication.
+ The ability to present technical, product and regulatory information clearly and concisely.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel required at 10% or less within the EMEA region.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics. The Regulatory Affairs Specialist for Cytiva is responsible for supporting regulatory compliance of Medical Devices placed on the market in EMEA.
This position is part of Medical Regulatory Affairs located in Portsmouth, UK and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
+ Compile all aspects of Technical Documentation for product certification under Regulation (EU) 2017/745 for Medical Devices.
+ Submit Technical Documentation to Notified Bodies for review and approval.
+ Support RA related QMS documentation, Complaints Assessment, Vigilance Reports and Change Controls.
+ Support medical device Regulatory Intelligence process and customer requests.
+ Provide support as required for UK Responsible Person with regard to the requirements set out in the UK MDR 2002 relating to medical devices.
+ Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager.
Who you are:
+ You have a Life Sciences degree or equivalent.
+ You have at least 2-3 years experience in a healthcare / life sciences industry in a regulatory or technical field.
+ Working knowledge of Medical Device regulations (EU MDR, MDCG guidelines, other EMEA), ISO 13485 and ISO 14971.
+ Experience with Quality Management System documentation.
+ Ability to communicate effectively across all departments and functions
+ Good attention to detail.
+ Have excellent English oral and written communication.
+ The ability to present technical, product and regulatory information clearly and concisely.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel required at 10% or less within the EMEA region.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
This advertiser has chosen not to accept applicants from your region.
4
Regulatory Affairs Specialist
Newquay, South West
Danaher Corporation
Posted 13 days ago
Job Viewed
Job Description
Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics. The Regulatory Affairs Specialist for Cytiva is responsible for supporting regulatory compliance of Medical Devices placed on the market in EMEA.
This position is part of Medical Regulatory Affairs located in Portsmouth, UK and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
+ Compile all aspects of Technical Documentation for product certification under Regulation (EU) 2017/745 for Medical Devices.
+ Submit Technical Documentation to Notified Bodies for review and approval.
+ Support RA related QMS documentation, Complaints Assessment, Vigilance Reports and Change Controls.
+ Support medical device Regulatory Intelligence process and customer requests.
+ Provide support as required for UK Responsible Person with regard to the requirements set out in the UK MDR 2002 relating to medical devices.
+ Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager.
Who you are:
+ You have a Life Sciences degree or equivalent.
+ You have at least 2-3 years experience in a healthcare / life sciences industry in a regulatory or technical field.
+ Working knowledge of Medical Device regulations (EU MDR, MDCG guidelines, other EMEA), ISO 13485 and ISO 14971.
+ Experience with Quality Management System documentation.
+ Ability to communicate effectively across all departments and functions
+ Good attention to detail.
+ Have excellent English oral and written communication.
+ The ability to present technical, product and regulatory information clearly and concisely.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel required at 10% or less within the EMEA region.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics. The Regulatory Affairs Specialist for Cytiva is responsible for supporting regulatory compliance of Medical Devices placed on the market in EMEA.
This position is part of Medical Regulatory Affairs located in Portsmouth, UK and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
+ Compile all aspects of Technical Documentation for product certification under Regulation (EU) 2017/745 for Medical Devices.
+ Submit Technical Documentation to Notified Bodies for review and approval.
+ Support RA related QMS documentation, Complaints Assessment, Vigilance Reports and Change Controls.
+ Support medical device Regulatory Intelligence process and customer requests.
+ Provide support as required for UK Responsible Person with regard to the requirements set out in the UK MDR 2002 relating to medical devices.
+ Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager.
Who you are:
+ You have a Life Sciences degree or equivalent.
+ You have at least 2-3 years experience in a healthcare / life sciences industry in a regulatory or technical field.
+ Working knowledge of Medical Device regulations (EU MDR, MDCG guidelines, other EMEA), ISO 13485 and ISO 14971.
+ Experience with Quality Management System documentation.
+ Ability to communicate effectively across all departments and functions
+ Good attention to detail.
+ Have excellent English oral and written communication.
+ The ability to present technical, product and regulatory information clearly and concisely.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel required at 10% or less within the EMEA region.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
This advertiser has chosen not to accept applicants from your region.
5
Regulatory Affairs Specialist
ConvaTec
Posted 13 days ago
Job Viewed
Job Description
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit search for better is changing the lives of our customers. It's changing the careers of our people too - creating new challenges and opportunities all the time. We're a business that never stands still. Join us on our journey to #ForeverCaring
Convatec Infusion Care is currently looking for a new colleague to join our dedicated Regulatory Affairs team. The RA department is responsible for Convatec Infusion Care product portfolio registration efforts and for ensuring local and worldwide regulatory compliance. You will be a part of a team of highly qualified and goal-oriented specialists who constantly aim at knowledge sharing, a high level of professionalism, and continuous improvement. While we set high standards for our work, we also strive for a healthy work-life balance and personal development. As our work is very dynamic, with many balls in the air at one time, you will have a unique opportunity to experience how a big corporation operates, conducts business, and has a positive impact on a global scale.
We offer you an impactful role in an innovative and far-reaching company. You will collaborate across the organisation and have a significant influence on the projects and processes assigned to you. Reporting to the Manager - Regulatory Affairs for the post Market activities, you will join a team of highly motivated employees. This position is located in Deeside, UK - with the flexibility of working from home when it fits with your tasks.
**Key Duties And Responsibilities**
+ Correspond with customers, appointed representatives in different countries and authorities regarding product registration;
+ Ensure that registrations fulfill regulatory requirements in relevant markets;
+ Maintain competence and knowledge regarding product registration and regulatory requirements in relevant markets ensuring that the impact of new regulations and changes in regulations are assessed and communicated within the organization, as required;
+ Obtain knowledge of regulatory requirements to develop regulatory strategies for product launch and support registration in new markets;
+ Provide regulatory support across the organization to ensure that the regulatory requirements are met, and that relevant product documentation is in place as required by regulatory authorities during the different stages of the product life cycle;
+ Ensure that documents are generated and maintained for the registration of new devices, changes to existing products, and notification of said changes to the regulatory authorities. These documents include but are not limited to Declarations of Conformity, Technical File Summaries, regulatory statements, etc;
+ Ensure maintenance of procedures and instructions related to Regulatory Affairs;
+ Maintain regulatory Information in relevant databases;
+ Ad hoc assistance within the regulatory field;
+ Assess regulatory impact for changes to existing as well as new products;
+ Sign documents related to products registration, according to the relevant procedures governing each document and in line with the responsibilities described above;
+ Sign documents related to the development of new products and changes to existing products;
+ Prepare, review, and sign Regulatory Assessment Plans.
**About You**
We are looking for a structured, positive, and team-oriented specialist. Additionally, you possess excellent communication and project management skills, along with comprehensive knowledge of worldwide regulations and MDR.
As a person who looks for solutions rather than obstacles, you take pride in being a specialist and aim to improve your personal and professional skills. You understand that the key contributing factor to success is collaboration with your closest colleagues and across functions. Delivering high-quality, timely solutions, and projects are top priorities for you. Having a strong grasp of good documentation practice, and habits of working in a structured and methodical manner, you know when to execute and delegate.
To be truly successful in this position you must enjoy cooperating within large project groups and having a busy workday while managing several tasks at the same time. You are fluent in English, in writing as well as verbally, as the company language is English.
**Your Qualifications And Experience**
+ Engineer or technical/bachelor degree as Pharmaconomist, Laboratory technician, or relevant work experience (required)
+ Customer service experience (preferred)
+ Work experience with product registration/market access of medical devices or pharmaceuticals (preferred)
+ Fluent English, verbal and written (required)
+ Familiar with commonly used computer software packages
+ Knowledge of regulations related to product registration (required)
+ Knowledge of ISO 13485 or similar regulations, (preferred)
Our transformation will change your career. For good. You'll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you'll be supported to bring them to life. There'll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet. This is stepping outside of your comfort zone.
This is work that'll **move** you.
#LI-AN1
#LI-Remote
**Beware of scams online or from individuals claiming to represent Convatec**
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you're unsure, please contact us at .
**Equal opportunities**
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
**Notice to Agency and Search Firm Representatives**
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
**Already a Convatec employee?**
**If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!**
Convatec Infusion Care is currently looking for a new colleague to join our dedicated Regulatory Affairs team. The RA department is responsible for Convatec Infusion Care product portfolio registration efforts and for ensuring local and worldwide regulatory compliance. You will be a part of a team of highly qualified and goal-oriented specialists who constantly aim at knowledge sharing, a high level of professionalism, and continuous improvement. While we set high standards for our work, we also strive for a healthy work-life balance and personal development. As our work is very dynamic, with many balls in the air at one time, you will have a unique opportunity to experience how a big corporation operates, conducts business, and has a positive impact on a global scale.
We offer you an impactful role in an innovative and far-reaching company. You will collaborate across the organisation and have a significant influence on the projects and processes assigned to you. Reporting to the Manager - Regulatory Affairs for the post Market activities, you will join a team of highly motivated employees. This position is located in Deeside, UK - with the flexibility of working from home when it fits with your tasks.
**Key Duties And Responsibilities**
+ Correspond with customers, appointed representatives in different countries and authorities regarding product registration;
+ Ensure that registrations fulfill regulatory requirements in relevant markets;
+ Maintain competence and knowledge regarding product registration and regulatory requirements in relevant markets ensuring that the impact of new regulations and changes in regulations are assessed and communicated within the organization, as required;
+ Obtain knowledge of regulatory requirements to develop regulatory strategies for product launch and support registration in new markets;
+ Provide regulatory support across the organization to ensure that the regulatory requirements are met, and that relevant product documentation is in place as required by regulatory authorities during the different stages of the product life cycle;
+ Ensure that documents are generated and maintained for the registration of new devices, changes to existing products, and notification of said changes to the regulatory authorities. These documents include but are not limited to Declarations of Conformity, Technical File Summaries, regulatory statements, etc;
+ Ensure maintenance of procedures and instructions related to Regulatory Affairs;
+ Maintain regulatory Information in relevant databases;
+ Ad hoc assistance within the regulatory field;
+ Assess regulatory impact for changes to existing as well as new products;
+ Sign documents related to products registration, according to the relevant procedures governing each document and in line with the responsibilities described above;
+ Sign documents related to the development of new products and changes to existing products;
+ Prepare, review, and sign Regulatory Assessment Plans.
**About You**
We are looking for a structured, positive, and team-oriented specialist. Additionally, you possess excellent communication and project management skills, along with comprehensive knowledge of worldwide regulations and MDR.
As a person who looks for solutions rather than obstacles, you take pride in being a specialist and aim to improve your personal and professional skills. You understand that the key contributing factor to success is collaboration with your closest colleagues and across functions. Delivering high-quality, timely solutions, and projects are top priorities for you. Having a strong grasp of good documentation practice, and habits of working in a structured and methodical manner, you know when to execute and delegate.
To be truly successful in this position you must enjoy cooperating within large project groups and having a busy workday while managing several tasks at the same time. You are fluent in English, in writing as well as verbally, as the company language is English.
**Your Qualifications And Experience**
+ Engineer or technical/bachelor degree as Pharmaconomist, Laboratory technician, or relevant work experience (required)
+ Customer service experience (preferred)
+ Work experience with product registration/market access of medical devices or pharmaceuticals (preferred)
+ Fluent English, verbal and written (required)
+ Familiar with commonly used computer software packages
+ Knowledge of regulations related to product registration (required)
+ Knowledge of ISO 13485 or similar regulations, (preferred)
Our transformation will change your career. For good. You'll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you'll be supported to bring them to life. There'll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet. This is stepping outside of your comfort zone.
This is work that'll **move** you.
#LI-AN1
#LI-Remote
**Beware of scams online or from individuals claiming to represent Convatec**
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you're unsure, please contact us at .
**Equal opportunities**
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
**Notice to Agency and Search Firm Representatives**
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
**Already a Convatec employee?**
**If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!**
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Regulatory affairs Jobs in United Kingdom !
6
Regulatory Affairs Submission Associate
Berkshire, South East
SRG
Posted today
Job Viewed
Job Description
Job Title: Regulatory Affairs Submission Associate
Location: Maidenhead
Contract: 12 months
Hours: 37.5 hours
Rates: 20-22p/h
Job Description
SRG are looking for a regulatory affairs submission associate for a pharmaceutical company based in maidenhead. You will be responsible for establishing and maintaining submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfils Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications.
Duties and Responsibilities
- Manages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
- Acts as Submission Management support to project teams providing guidance and communication of established submission processes and standards. Provides input to project publishing timelines and deliverables.
- Participates in submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects in the delivery of low to moderately complex published submissions within the required timelines. Anticipates obstacles and proposes solutions within the team.
- Coordinates submission publishing with offsite publishers/provides notification to ensure resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues
- Facilitates the creation or procurement of submission content deliverables such as cover letters and forms
- Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance's including verification of content, bookmarks, hypertext links and tables of content in low to moderately complex submissions. Facilitates team reviews.
- Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions. Contributes to the implementation of internal process and standards documents relating to publishing and publishing deliverables.
- Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.
- Demonstrates ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
- Position accountability/scope:
- Supervision required
- Receives project assignments from manager but has responsibility for managing own projects with oversight
- Reviews project progress with manager on a regular basis with direction provided by manager
- May assist with onboarding staff.
Experience and Qualifications
Bachelor's degree
Note: Years of experience may also compensate for lower education.
PMP and RAC certificates are desirable.
Competencies
- Pharmaceutical or industry related experience
- Experience working in a complex and matrix environment
- Strong communication skills both oral and written
- Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area
- Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
- Proven leadership skills and presence
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
This advertiser has chosen not to accept applicants from your region.
7
Senior Regulatory Affairs Associate
Cambridgeshire, Eastern
£40000 - £45000 Annually
SciPro
Posted 6 days ago
Job Viewed
Job Description
SciPro have exclusively partnered with an innovative pharmaceutical company who are driven by their purpose to reimagine how drugs can improve the quality of life of patients with rare disease. They are a fast growing, agile organization transforming the lives of patients and care givers through the use of cutting-edge pharmaceutical technologies to translate pioneering science to medicine products.
We are supporting them on their search for a Senior Regulatory Affairs Associate to lead compliant product labelling and artwork of their product portfolio. You will join the Regulatory Affairs team in the UK and have the chance to make a real impact on multiple projects to support the company growth and ultimately, make a difference to the patients the company support.
Key Responsibilities:
- Lead U.S. labelling and artwork activities
- Lead the preparation of ANDA/NDA submissions
- Lead promotional material submissions to the FDA
Key Requirements :
- 4+ years of regulatory affairs experience
- Experience with Adobe Illustrator or Adobe InDesign
- Prior experience with US FDA regulations
This advertiser has chosen not to accept applicants from your region.
8
Regulatory Affairs Submission Associate
SL6 Maidenhead, South East
SRG
Posted today
Job Viewed
Job Description
Job Title: Regulatory Affairs Submission Associate
Location: Maidenhead
Contract: 12 months
Hours: 37.5 hours
Rates: 20-22p/h
Job Description
SRG are looking for a regulatory affairs submission associate for a pharmaceutical company based in maidenhead. You will be responsible for establishing and maintaining submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfils Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications.
Duties and Responsibilities
- Manages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
- Acts as Submission Management support to project teams providing guidance and communication of established submission processes and standards. Provides input to project publishing timelines and deliverables.
- Participates in submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects in the delivery of low to moderately complex published submissions within the required timelines. Anticipates obstacles and proposes solutions within the team.
- Coordinates submission publishing with offsite publishers/provides notification to ensure resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues
- Facilitates the creation or procurement of submission content deliverables such as cover letters and forms
- Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance's including verification of content, bookmarks, hypertext links and tables of content in low to moderately complex submissions. Facilitates team reviews.
- Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions. Contributes to the implementation of internal process and standards documents relating to publishing and publishing deliverables.
- Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.
- Demonstrates ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
- Position accountability/scope:
- Supervision required
- Receives project assignments from manager but has responsibility for managing own projects with oversight
- Reviews project progress with manager on a regular basis with direction provided by manager
- May assist with onboarding staff.
Experience and Qualifications
Bachelor's degree
Note: Years of experience may also compensate for lower education.
PMP and RAC certificates are desirable.
Competencies
- Pharmaceutical or industry related experience
- Experience working in a complex and matrix environment
- Strong communication skills both oral and written
- Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area
- Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
- Proven leadership skills and presence
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
This advertiser has chosen not to accept applicants from your region.
9