93 Regulatory Affairs Specialist jobs in the United Kingdom

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!**

Our client , a pioneering pharmaceutical company, is seeking a dedicated Regulatory Affairs Specialist to join their expert team in Reading, Berkshire, UK . This role is critical in ensuring that all products meet the stringent regulatory requirements for market approval and ongoing compliance. You will be involved in preparing and submitting regulatory dossiers, liaising with health authorities, and staying abreast of evolving global regulations.

Key Responsibilities:

• Prepare, review, and submit regulatory documentation for product registrations, variations, and renewals to health authorities worldwide.
• Ensure compliance with all applicable national and international pharmaceutical regulations (e.g., EMA, FDA, MHRA).
• Liaise with regulatory agencies on behalf of the company, responding to queries and managing communications.
• Monitor and interpret new and updated regulatory guidelines and assess their impact on the company's products and processes.
• Develop and maintain regulatory strategies for new product development and lifecycle management.
• Review and approve marketing materials, labelling, and packaging to ensure regulatory compliance.
• Manage post-approval regulatory activities, including annual reports and safety updates.
• Collaborate with R&D, Quality Assurance, Medical Affairs, and Commercial departments to provide regulatory guidance and support.
• Maintain regulatory databases and filing systems.
• Contribute to the development and implementation of internal regulatory SOPs.
• Support due diligence activities for potential partnerships or acquisitions.
• Provide training on regulatory requirements to relevant personnel.
• Participate in cross-functional project teams to ensure regulatory considerations are integrated into product development.

Qualifications:

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline. Master's degree preferred.
• Minimum of 3 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
• Comprehensive knowledge of global pharmaceutical regulatory requirements and submission processes.
• Experience with preparing and submitting Common Technical Document (CTD) dossiers.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills, with a keen eye for detail.
• Ability to manage multiple projects and deadlines effectively.
• Proficiency in regulatory information management systems and Microsoft Office Suite.
• Strong understanding of drug development processes.

This is an exceptional opportunity for a motivated Regulatory Affairs Specialist to contribute to a leading pharmaceutical company, ensuring their innovative products reach patients safely and effectively in a key Thames Valley location.

ABOUT ORGANOX:

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra ® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

Position Summary

The Regulatory Affairs Specialist is responsible for performing regulatory administration and support activities for OrganOx Limited.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

This is an office based role in Oxford with flexibility.

Major Responsibilities

Under direction from the Regulatory Affairs Manager, the Regulatory Affairs Specialist will be responsible for:

• Perform and/or coordinate regulatory documentation updates as requested by the Regulatory Affairs Manager to support the relevant department(s) in fulfilling regulatory requirements
• Under the instruction of the Regulatory Affairs Manager, perform administration and compilation of documentation needed for regulatory submissions
• Working with wider team members to gather required information for change submissions to the Notified Body
• Assist with submission of change requests to the Notified Body (NB), logging NB responses or approvals and assisting with any requests for further information.
• Assist the Regulatory Affairs Manager with maintenance and creation of product registrations and certifications
• Support the Regulatory Affairs Manager with data gathering and analysis for trend reporting into Post Market Surveillance activities
• Work with the Global Labelling and Compliance Manager and Regulatory Affairs Manager to maintain regulatory information within OrganOx’s Regulatory Information Management Software, RIMSYS
• Assist with training for new and existing employees on the RIMSYS Regulatory Information Management Platform
• Assist the Global Labelling and Compliance Manager to maintain Technical File documentation
• Assist the Global Labelling and Compliance Manager with maintenance and control of product labelling
• Assist during notified body audits
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

Requirements

Skills & Experience

• Demonstrable experience in regulatory affairs or quality within the medical device industry
• Experience working within ISO 13485:2016 quality management system
• The ability to work within a fast paced, changing environment and comfortable dealing with ambiguity
• Experience of administration of documentation for regulatory submissions (Desirable)
• Experience in maintenance of medical device registrations EU/UK (Desirable)
• High level of attention to detail
• Strong scientific writing skills
• Proficient in Microsoft Word and Excel
• Excellent organization skills

Qualifications

• A bachelor’s degree is preferred but not essential

Benefits

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law.

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youu2019ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.



**A Day in the Life**

Medtronic is among the largest medical technology companies in the world. Through innovation and collaboration, Medtronic helps to alleviate pain, restore health and extend life. Last year, our medical therapies for the treatment of over 40 major conditions, improved the lives of more than 75 million people around the world.



We are looking for an entry level Associate Regulatory Affairs Specialist for post-market regulatory product support including field safety corrective actions, competent authority requests for information, complaint process support, product documentation and support requests from customers, sales and tenders teams, and other internal stakeholders. You will get the benefit of hybrid work - Tuesdays and Wednesdays from Watford, UK office and the rest of the week from home.



**Responsibilities may include the following and other duties may be assigned:**


Preparation, execution and follow up of FSCA (field safety corrective actions) according to the enterprise plan. Close collaboration with the sales managers and sales representatives to collect/record evidence, allowing timely closure of the UK/Ireland Field Actions. Reconciliation activities in collaboration with the FCA Support Team.
Follow up on inquiries from the Competent Authority to i.e., Field Action or Vigilance activities. This includes updating the Medtronic reporting systems and record keeping.
Support on Post-Market Surveillance - provide advice to sales team members on product complaint handling processes and returns, to assure compliance to UK/Ireland Regulations and Medtronic procedures
Monitors the shared mailbox by providing support to tender requests, customer requests, internal stakeholder requests
Sourcing, verifying and providing regulatory documents to customers and other stakeholders
Connecting requests to the appropriate Organizational Unit and ensuring complete follow up
Maintaining training completion, participation in team and process improvement initiatives



**Required Knowledge and Experience:**


Degree in Engineering, Life-science, Biology or another relevant advanced degree OR 3-5 years of medical device regulatory experience
Advanced computer skills (Microsoft Office including advanced Excel skills and ability to use custom organizational software)
Critical Thinking and problem solving
Autonomy and proactivity, continuous learning, attention to detail
Organizational and strong administrative skills, including self- organisation and task tracking
Clear communication, proficient English language to allow for stakeholder management and influencing
Quality orientation and patient safety focused, curiosity and high interest in the medical device field



**Physical Job Requirements**



The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.u202f



**Benefits & Compensation**



**Medtronic offers a competitive Salary and flexible Benefits Package**

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.



**About Medtronic**



We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission u2014 to alleviate pain, restore health, and extend life u2014 unites a global team of 95,000+ passionate people.

We are engineers at heartu2014 putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.



Learn more about our business, mission, and our commitment to diversity here (


We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.



Our Mission u2014 to alleviate pain, restore health, and extend life u2014 unites a global team of 95,000+ passionate people.



We are engineers at heartu2014 putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.



**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. Thatu2019s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.



**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.



**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you willu2026


**Build** a better future, amplifying your impact on the causes that matter to you and the world
**Grow** a career reflective of your passion and abilities
**Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning



These commitments set our team apart from the rest:



**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.



**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.



**Better outcomes for our world** . Here, itu2019s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.



**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care



It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.



For sales reps and other patient facing field employees, going into a healthcare settingu202fis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.



This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .



For updates on job applications, please go to the candidate login page and sign in to check your application status.



If you need assistance completing your application please email



To request removal of your personal information from our systems please email

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youu2019ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.



**A Day in the Life**

Medtronic is among the largest medical technology companies in the world. Through innovation and collaboration, Medtronic helps to alleviate pain, restore health and extend life. Last year, our medical therapies for the treatment of over 40 major conditions, improved the lives of more than 75 million people around the world.



We are looking for an entry level Associate Regulatory Affairs Specialist for post-market regulatory product support including field safety corrective actions, competent authority requests for information, complaint process support, product documentation and support requests from customers, sales and tenders teams, and other internal stakeholders. You will get the benefit of hybrid work - Tuesdays and Wednesdays from Watford, UK office and the rest of the week from home.



**Responsibilities may include the following and other duties may be assigned:**


Preparation, execution and follow up of FSCA (field safety corrective actions) according to the enterprise plan. Close collaboration with the sales managers and sales representatives to collect/record evidence, allowing timely closure of the UK/Ireland Field Actions. Reconciliation activities in collaboration with the FCA Support Team.
Follow up on inquiries from the Competent Authority to i.e., Field Action or Vigilance activities. This includes updating the Medtronic reporting systems and record keeping.
Support on Post-Market Surveillance - provide advice to sales team members on product complaint handling processes and returns, to assure compliance to UK/Ireland Regulations and Medtronic procedures
Monitors the shared mailbox by providing support to tender requests, customer requests, internal stakeholder requests
Sourcing, verifying and providing regulatory documents to customers and other stakeholders
Connecting requests to the appropriate Organizational Unit and ensuring complete follow up
Maintaining training completion, participation in team and process improvement initiatives



**Required Knowledge and Experience:**


Degree in Engineering, Life-science, Biology or another relevant advanced degree OR 3-5 years of medical device regulatory experience
Advanced computer skills (Microsoft Office including advanced Excel skills and ability to use custom organizational software)
Critical Thinking and problem solving
Autonomy and proactivity, continuous learning, attention to detail
Organizational and strong administrative skills, including self- organisation and task tracking
Clear communication, proficient English language to allow for stakeholder management and influencing
Quality orientation and patient safety focused, curiosity and high interest in the medical device field



**Physical Job Requirements**



The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.u202f



**Benefits & Compensation**



**Medtronic offers a competitive Salary and flexible Benefits Package**

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.



**About Medtronic**



We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission u2014 to alleviate pain, restore health, and extend life u2014 unites a global team of 95,000+ passionate people.

We are engineers at heartu2014 putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.



Learn more about our business, mission, and our commitment to diversity here (


We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.



Our Mission u2014 to alleviate pain, restore health, and extend life u2014 unites a global team of 95,000+ passionate people.



We are engineers at heartu2014 putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.



**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. Thatu2019s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.



**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.



**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you willu2026


**Build** a better future, amplifying your impact on the causes that matter to you and the world
**Grow** a career reflective of your passion and abilities
**Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning



These commitments set our team apart from the rest:



**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.



**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.



**Better outcomes for our world** . Here, itu2019s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.



**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care



It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.



For sales reps and other patient facing field employees, going into a healthcare settingu202fis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.



This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .



For updates on job applications, please go to the candidate login page and sign in to check your application status.



If you need assistance completing your application please email



To request removal of your personal information from our systems please email

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
Medtronic is among the largest medical technology companies in the world. Through innovation and collaboration, Medtronic helps to alleviate pain, restore health and extend life. Last year, our medical therapies for the treatment of over 40 major conditions, improved the lives of more than 75 million people around the world.
We are looking for an entry level Associate Regulatory Affairs Specialist for post-market regulatory product support including field safety corrective actions, competent authority requests for information, complaint process support, product documentation and support requests from customers, sales and tenders teams, and other internal stakeholders. You will get the benefit of hybrid work - Tuesdays and Wednesdays from Watford, UK office and the rest of the week from home.
**Responsibilities may include the following and other duties may be assigned:**
+ Preparation, execution and follow up of FSCA (field safety corrective actions) according to the enterprise plan. Close collaboration with the sales managers and sales representatives to collect/record evidence, allowing timely closure of the UK/Ireland Field Actions. Reconciliation activities in collaboration with the FCA Support Team.
+ Follow up on inquiries from the Competent Authority to i.e., Field Action or Vigilance activities. This includes updating the Medtronic reporting systems and record keeping.
+ Support on Post-Market Surveillance - provide advice to sales team members on product complaint handling processes and returns, to assure compliance to UK/Ireland Regulations and Medtronic procedures
+ Monitors the shared mailbox by providing support to tender requests, customer requests, internal stakeholder requests
+ Sourcing, verifying and providing regulatory documents to customers and other stakeholders
+ Connecting requests to the appropriate Organizational Unit and ensuring complete follow up
+ Maintaining training completion, participation in team and process improvement initiatives
**Required Knowledge and Experience:**
+ Degree in Engineering, Life-science, Biology or another relevant advanced degree OR 3-5 years of medical device regulatory experience
+ Advanced computer skills (Microsoft Office including advanced Excel skills and ability to use custom organizational software)
+ Critical Thinking and problem solving
+ Autonomy and proactivity, continuous learning, attention to detail
+ Organizational and strong administrative skills, including self- organisation and task tracking
+ Clear communication, proficient English language to allow for stakeholder management and influencing
+ Quality orientation and patient safety focused, curiosity and high interest in the medical device field
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email

**Principal Regulatory Affairs Specialist**
**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 Principal Regulatory Affairs Specialist 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**
This position is responsible for planning, creating and implementing solutions for regulatory registration and release of products for distribution into specific geographies.
**Core Job Responsibilities**
+ Executes and Ensures Product Registration,
+ Release Authorization and Release for Distribution.
+ Oversee processes and team involved with obtaining and maintaining product registration, release authorization and release of product to specified geographies.
+ Coordinates with cross functional teams including but not limited to: US Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release.
+ Identify risk areas and escalate issues as appropriate.
+ Manage multiple programs with minimal oversight.
+ Product Release Process Ownership
+ Develops processes and tools to support controlled product release. Responsible for development, maintenance and compliance with applicable Corporate and Divisional Policies and procedures.
+ Product Registration, Release Authorization and Release Planning
+ Provide Regulatory input to product lifecycle planning
+ Provide Regulatory input to strategy based upon regulatory changes
+ Identify and react to emerging issues
+ Analyse product-associated problems and develop proposals for solutions Acts as a liaison with other departments, e.g., Quality, R&D, Legal, Operations, Marketing and Clinical Affairs, for major initiatives.
+ Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback.
+ Maintains a safe and professional work environment.
+ Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
+ Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
+ Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
**Position Accountability / Scope**
+ Ensure timely registration of all current and new ADC products with the appropriate regulatory authorities.
+ Plan and manage the non-project-related workload of Regulatory team members to maintain efficiency and alignment with departmental goals.
+ Oversee the accurate and efficient management of regulatory systems to ensure traceability and accessibility of records for future reference.
+ Supervise Regulatory team members in developing strategies for both project and non-project-related workstreams.
+ Support the line manager in shaping and executing departmental-level Regulatory strategies.
**Minimum** **Education**
+ Educated to degree level or equivalent preferably in a Scientific discipline e.g., Chemistry, life Sciences, Biology.
**Minimum** **Experience/Training Required**
+ The ideal candidate will hold a degree (or equivalent qualification), preferably in a Science or Engineering discipline, and will have prior experience in Regulatory Affairs within the Medical Device or In Vitro Diagnostics (IVD) sector.
We are particularly looking for individuals with:
+ A solid understanding of the EU Medical Device Regulation (MDR - Regulation (EU) 2017/745) and/or the In Vitro Diagnostic Medical Device Regulation (IVDR - Regulation (EU) 2017/746)
+ Experience working within an ISO 13485-certified Quality Management System
+ Proven international registration experience, ideally with a focus on Asia Pacific markets
+ Proficiency in Chinese is considered a strong advantage
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