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 internat