279 Regulatory Affairs Specialist jobs in the United Kingdom

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 .

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 .

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 .

Our client, a prominent pharmaceutical company committed to ensuring the highest standards of safety and efficacy, is seeking a diligent and experienced Regulatory Affairs Specialist to join their team in Wolverhampton, West Midlands, UK . This role is critical in navigating the complex landscape of pharmaceutical regulations, ensuring that all products meet stringent global compliance requirements. The ideal candidate will possess a comprehensive understanding of regulatory guidelines, submission processes, and quality management systems within the pharmaceutical industry.

You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and providing expert guidance on regulatory strategy. Your expertise will be vital in supporting product approvals, lifecycle management, and maintaining compliance throughout the product's journey. This position demands meticulous attention to detail, strong analytical skills, and excellent communication abilities to effectively collaborate with internal departments and external regulatory bodies.

Key Responsibilities:

• Prepare, review, and submit regulatory dossiers and applications for new drug products and variations in accordance with global regulatory requirements (e.g., FDA, EMA, MHRA).
• Liaise directly with regulatory authorities to address queries, facilitate submissions, and manage approvals.
• Provide regulatory strategy advice and support to R&D, manufacturing, and marketing teams.
• Ensure compliance with all applicable pharmaceutical regulations, guidelines, and company policies.
• Maintain up-to-date knowledge of evolving regulatory landscapes and industry best practices.
• Oversee post-approval changes and variations to ensure continued compliance.
• Review and approve promotional materials and labeling for regulatory compliance.
• Participate in regulatory inspections and audits.
• Develop and maintain regulatory databases and filing systems.
• Support the development and implementation of quality management systems.
• Contribute to the risk assessment and mitigation of regulatory challenges.
• Collaborate with external partners and contract manufacturers on regulatory matters.

Qualifications:

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• Minimum of 3-5 years of progressive experience in pharmaceutical regulatory affairs.
• Demonstrated experience in preparing and submitting regulatory dossiers (e.g., CTD, IND, NDA).
• In-depth knowledge of global regulatory requirements and guidelines (FDA, EMA, MHRA).
• Familiarity with quality management systems and GMP/ICH guidelines.
• Excellent written and verbal communication skills, with a strong ability to draft clear and concise regulatory documents.
• Strong analytical and problem-solving abilities.
• Detail-oriented with exceptional organizational skills.
• Ability to manage multiple projects and meet strict deadlines.
• Proficiency in regulatory information management systems is a plus.
• Experience working within a pharmaceutical manufacturing or R&D environment in Wolverhampton or similar.

This role offers a significant opportunity to contribute to patient safety and access to medicines by ensuring regulatory compliance. Our client provides a competitive salary, excellent benefits, and professional development opportunities within a supportive and collaborative environment.

We anticipate the application window for this opening will close on - 19 Oct 2025At 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 LifeAt 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.The Senior Regulatory Affairs Specialist role will both lead and support the review of advertising and promotional materials for MiniMed diabetes products across Europe, the Middle East, and Africa (EMEA), plus the UK and Ireland. This role ensures compliance with regional regulations, working closely with cross-functional teams (marketing, clinical, and international regulatory colleagues, consulting with legal when needed) to enable innovative and compliant product communication. A remote based position in country or from the United States is possible, with travel to onsite meetings in North America about twice per year.This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.Key responsibilities may include the following and other duties may be assigned.Review and approve EMEA and UKI advertising and promotional materials for diabetes products ensuring compliance with local, regional, and international regulations.Collaborate with regulatory, legal, marketing, and international regulatory teams to ensure clarity and accuracy of promotional claims.Work with Medical Affairs to confirm and align claims according to clinical trial publications and clinical data.Advise on regulatory requirements and best practices for product advertising and promotion in EMEA.Monitor global regulatory changes and trends and competitor activity, proactively communicating changes to internal teams and contribute to updating processes.Coordinate with regulatory specialist teammates’ submissions and required documentation related to indications for use, regulator interactive review, etc.Provide training and guidance to internal stakeholders on regulatory standards and company risk tolerance for advertising and promotion.Must Have: Minimum RequirementsBachelor’s degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.ORAdvanced Degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review. Nice to HaveAdvanced degree (Master’s or equivalent).Experience with diabetes-related products or devices.4+ years of U.S. and EU regulatory submission experience (preferred 510(k) and Technical Documentation)Proficient understanding of EU MDR, FDA requirements.Knowledge of Medical Device Quality SystemsExperience working with international, cross-functional, and core-teams.Product launch experience.Understanding of corporate goals, product pipeline, disease state, customer needs, reimbursement, and competitive environment.Experience with Agile, Veeva PromoMats.Demonstrated experience in reviewing advertising and promotional materials in either Europe, United States, or Canada (EMEA experience preferred).Strong knowledge of medical device regulations, including EU MDR, UK MHRA, US FDA and /or regional advertising standards.Ability to interpret clinical data and publications in the context of promotional claims.Exceptional attention to detail and strong communication skills.Experience collaborating in cross-functional and international teams.Strong oral and written communication skills.Effective interpersonal skills.Effective team member.Proficient skills with MS Word, MS Outlook, MS Excel, MS PowerPoint.Physical Job RequirementsThe 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. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits PackageA 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. Salary ranges for U.S (excl. PR) locations (USD):$92,000.00 - $138,000.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance,Health Savings Account,Healthcare Flexible Spending Account,Life insurance, Long-term disability leave,Dependent daycare spending account,Tuition assistance/reimbursement, andSimple Steps (global well-being program).The following benefits and additional compensation are available to all regular employees:Incentive plans, 401(k) plan plus employer contribution and match,Short-term disability,Paid time off,Paid holidays,Employee Stock Purchase Plan,Employee Assistance Program,Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.Further details are available at the link below:About MedtronicWe 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 .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.If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We anticipate the application window for this opening will close on - 19 Oct 2025



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**

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.



The Senior Regulatory Affairs Specialist role will both lead and support the review of advertising and promotional materials for MiniMed diabetes products across Europe, the Middle East, and Africa (EMEA), plus the UK and Ireland. This role ensures compliance with regional regulations, working closely with cross-functional teams (marketing, clinical, and international regulatory colleagues, consulting with legal when needed) to enable innovative and compliant product communication.



A remote based position in country or from the United States is possible, with travel to onsite meetings in North America about twice per year.

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.



Key responsibilities may include the following and other duties may be assigned.


Review and approve EMEA and UKI advertising and promotional materials for diabetes products ensuring compliance with local, regional, and international regulations.
Collaborate with regulatory, legal, marketing, and international regulatory teams to ensure clarity and accuracy of promotional claims.
Work with Medical Affairs to confirm and align claims according to clinical trial publications and clinical data.
Advise on regulatory requirements and best practices for product advertising and promotion in EMEA.
Monitor global regulatory changes and trends and competitor activity, proactively communicating changes to internal teams and contribute to updating processes.
Coordinate with regulatory specialist teammatesu2019 submissions and required documentation related to indications for use, regulator interactive review, etc.
Provide training and guidance to internal stakeholders on regulatory standards and company risk tolerance for advertising and promotion.



**Must Have: Minimum Requirements**

_To be considered for this role, please ensure the minimum requirements are evident in your applicant profile._



Bacheloru2019s degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.



OR



Advanced Degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.



**Nice to Have**


Advanced degree (Masteru2019s or equivalent).
Experience with diabetes-related products or devices.
4+ years of U.S. and EU regulatory submission experience (preferred 510(k) and Technical Documentation)
Proficient understanding of EU MDR, FDA requirements.
Knowledge of Medical Device Quality Systems
Experience working with international, cross-functional, and core-teams.
Product launch experience.
Understanding of corporate goals, product pipeline, disease state, customer needs, reimbursement, and competitive environment.
Experience with Agile, Veeva PromoMats.
Demonstrated experience in reviewing advertising and promotional materials in either Europe, United States, or Canada (EMEA experience preferred).
Strong knowledge of medical device regulations, including EU MDR, UK MHRA, US FDA and /or regional advertising standards.
Ability to interpret clinical data and publications in the context of promotional claims.
Exceptional attention to detail and strong communication skills.
Experience collaborating in cross-functional and international teams.
Strong oral and written communication skills.
Effective interpersonal skills.
Effective team member.
Proficient skills with MS Word, MS Outlook, MS Excel, MS PowerPoint.



**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



The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.



**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.



Salary ranges for U.S (excl. PR) locations (USD):$92,000.00 - $138,000.00



This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).



The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).



The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).



The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).



Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.



Further details are available at the link below:



Medtronic benefits and compensation plans (


**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 ( .



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.



If you are applying to perform work for Medtronic, Inc. (u201cMedtronicu201d) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here ( a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.



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

We anticipate the application window for this opening will close on - 19 Oct 2025



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**

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.



The Senior Regulatory Affairs Specialist role will both lead and support the review of advertising and promotional materials for MiniMed diabetes products across Europe, the Middle East, and Africa (EMEA), plus the UK and Ireland. This role ensures compliance with regional regulations, working closely with cross-functional teams (marketing, clinical, and international regulatory colleagues, consulting with legal when needed) to enable innovative and compliant product communication.



A remote based position in country or from the United States is possible, with travel to onsite meetings in North America about twice per year.

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.



Key responsibilities may include the following and other duties may be assigned.


Review and approve EMEA and UKI advertising and promotional materials for diabetes products ensuring compliance with local, regional, and international regulations.
Collaborate with regulatory, legal, marketing, and international regulatory teams to ensure clarity and accuracy of promotional claims.
Work with Medical Affairs to confirm and align claims according to clinical trial publications and clinical data.
Advise on regulatory requirements and best practices for product advertising and promotion in EMEA.
Monitor global regulatory changes and trends and competitor activity, proactively communicating changes to internal teams and contribute to updating processes.
Coordinate with regulatory specialist teammatesu2019 submissions and required documentation related to indications for use, regulator interactive review, etc.
Provide training and guidance to internal stakeholders on regulatory standards and company risk tolerance for advertising and promotion.



**Must Have: Minimum Requirements**

_To be considered for this role, please ensure the minimum requirements are evident in your applicant profile._



Bacheloru2019s degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.



OR



Advanced Degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.



**Nice to Have**


Advanced degree (Masteru2019s or equivalent).
Experience with diabetes-related products or devices.
4+ years of U.S. and EU regulatory submission experience (preferred 510(k) and Technical Documentation)
Proficient understanding of EU MDR, FDA requirements.
Knowledge of Medical Device Quality Systems
Experience working with international, cross-functional, and core-teams.
Product launch experience.
Understanding of corporate goals, product pipeline, disease state, customer needs, reimbursement, and competitive environment.
Experience with Agile, Veeva PromoMats.
Demonstrated experience in reviewing advertising and promotional materials in either Europe, United States, or Canada (EMEA experience preferred).
Strong knowledge of medical device regulations, including EU MDR, UK MHRA, US FDA and /or regional advertising standards.
Ability to interpret clinical data and publications in the context of promotional claims.
Exceptional attention to detail and strong communication skills.
Experience collaborating in cross-functional and international teams.
Strong oral and written communication skills.
Effective interpersonal skills.
Effective team member.
Proficient skills with MS Word, MS Outlook, MS Excel, MS PowerPoint.



**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



The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.



**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.



Salary ranges for U.S (excl. PR) locations (USD):$92,000.00 - $138,000.00



This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).



The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).



The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).



The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).



Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.



Further details are available at the link below:



Medtronic benefits and compensation plans (


**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 ( .



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.



If you are applying to perform work for Medtronic, Inc. (u201cMedtronicu201d) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here ( a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.



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

We anticipate the application window for this opening will close on - 19 Oct 2025
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**
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.
The Senior Regulatory Affairs Specialist role will both lead and support the review of advertising and promotional materials for MiniMed diabetes products across Europe, the Middle East, and Africa (EMEA), plus the UK and Ireland. This role ensures compliance with regional regulations, working closely with cross-functional teams (marketing, clinical, and international regulatory colleagues, consulting with legal when needed) to enable innovative and compliant product communication.
A remote based position in country or from the United States is possible, with travel to onsite meetings in North America about twice per year.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Key responsibilities may include the following and other duties may be assigned.
+ Review and approve EMEA and UKI advertising and promotional materials for diabetes products ensuring compliance with local, regional, and international regulations.
+ Collaborate with regulatory, legal, marketing, and international regulatory teams to ensure clarity and accuracy of promotional claims.
+ Work with Medical Affairs to confirm and align claims according to clinical trial publications and clinical data.
+ Advise on regulatory requirements and best practices for product advertising and promotion in EMEA.
+ Monitor global regulatory changes and trends and competitor activity, proactively communicating changes to internal teams and contribute to updating processes.
+ Coordinate with regulatory specialist teammates' submissions and required documentation related to indications for use, regulator interactive review, etc.
+ Provide training and guidance to internal stakeholders on regulatory standards and company risk tolerance for advertising and promotion.
**Must Have: Minimum Requirements**
_To be considered for this role, please ensure the minimum requirements are evident in your applicant profile._
Bachelor's degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
OR
Advanced Degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
**Nice to Have**
+ Advanced degree (Master's or equivalent).
+ Experience with diabetes-related products or devices.
+ 4+ years of U.S. and EU regulatory submission experience (preferred 510(k) and Technical Documentation)
+ Proficient understanding of EU MDR, FDA requirements.
+ Knowledge of Medical Device Quality Systems
+ Experience working with international, cross-functional, and core-teams.
+ Product launch experience.
+ Understanding of corporate goals, product pipeline, disease state, customer needs, reimbursement, and competitive environment.
+ Experience with Agile, Veeva PromoMats.
+ Demonstrated experience in reviewing advertising and promotional materials in either Europe, United States, or Canada (EMEA experience preferred).
+ Strong knowledge of medical device regulations, including EU MDR, UK MHRA, US FDA and /or regional advertising standards.
+ Ability to interpret clinical data and publications in the context of promotional claims.
+ Exceptional attention to detail and strong communication skills.
+ Experience collaborating in cross-functional and international teams.
+ Strong oral and written communication skills.
+ Effective interpersonal skills.
+ Effective team member.
+ Proficient skills with MS Word, MS Outlook, MS Excel, MS PowerPoint.
**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. 
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
**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.
Salary ranges for U.S (excl. PR) locations (USD):$92,000.00 - $138,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans ( 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 ( .
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.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here ( a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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.
**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

Our client, a prominent pharmaceutical company renowned for its commitment to innovation and patient well-being, is seeking a highly skilled Senior Regulatory Affairs Specialist. This challenging role is based in our client's offices in Leicester, Leicestershire, UK , with a flexible hybrid working arrangement. You will play a critical role in ensuring our client's medicinal products comply with all relevant national and international regulatory requirements throughout their lifecycle, from development and registration to post-market surveillance.

Your key responsibilities will include:

• Preparing, reviewing, and submitting regulatory dossiers (e.g., CTD, MAA, NDA) for new drug applications and variations to existing marketing authorizations.
• Interpreting and advising on complex regulatory guidelines and legislation impacting the pharmaceutical industry.
• Liaising effectively with regulatory authorities (e.g., MHRA, EMA) to facilitate the approval process and address queries.
• Developing and implementing regulatory strategies to support product development and lifecycle management.
• Assessing the regulatory impact of proposed product changes, labelling updates, and promotional materials.
• Collaborating with internal stakeholders, including R&D, Clinical Operations, Quality Assurance, and Commercial teams, to ensure regulatory compliance.
• Staying current with evolving regulatory landscapes and providing proactive guidance on potential challenges and opportunities.
• Managing regulatory submissions and ensuring timely approvals in target markets.
• Contributing to the development and maintenance of regulatory procedures and policies.
• Reviewing and approving technical documentation for regulatory purposes.

The ideal candidate will hold a degree in Pharmacy, Life Sciences, Chemistry, or a related discipline, potentially supplemented by a Master's degree or relevant professional qualification. A minimum of 5-7 years of direct experience in pharmaceutical regulatory affairs is required, with a proven track record of successful regulatory submissions and approvals. Strong knowledge of regulatory frameworks in key markets (e.g., UK, EU, US) is essential. Excellent analytical, communication, and negotiation skills are critical, as is the ability to work independently and manage multiple complex projects simultaneously. Experience with specific therapeutic areas may be advantageous. This is a fantastic opportunity for a seasoned regulatory professional to contribute to a company dedicated to improving global health.