We anticipate the application window for this opening will close on - 14 Nov 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

The Principal Regulatory Affairs Specialist (Prin. RAS) is responsible for developing regulatory strategy, preparing US and EU submissions and obtaining approval to introduce and maintain Medtronic Diabetes products and therapies to US and EU markets.
This role focuses on drug delivery hardware based devices and software products within the Medtronic Diabetes Group. In this role, you will have primary RA responsibility for multiple Class II and Class III products in the US and EU, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.
• Position is 100% remote.
• Ability to travel, up to 10%, as business and local policies allow.

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.

A Day in the Life

The Principal RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required. 

Primary responsibilities include:

• Developing global regulatory strategies

• Preparing US and EU submissions

• Providing documentation for international submissions;

• Supporting post-market regulatory compliance activities;

• Evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables. 

• Develop and refine least burdensome regulatory strategies to support innovations in the Diabetes business with stakeholders across the business—US, EU, international regulatory teams as well as from various partner functions within product development teams, quality, R&D, clinical, etc.

• Apply regulatory standards, guidance documents, and industry expectations to product strategies and submissions for drug delivery devices. Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.

• Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.

• Lead negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance.

• Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.    

• Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.

Must Have: Minimum Requirements

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

Bachelor’s Degree and minimum of 7 years of medical device regulatory experience

OR

Advanced Degree and minimum of 5 years of medical device regulatory experience  

Nice to Have

• History of successful device submissions in the US and EU with both Class II and Class III devices

• Medical Device Experience: Direct experience in the medical device industry, particularly with Class III/II medical devices for both FDA and EU. Experience with drug delivery hardware devices, and associated submissions strongly preferred.

• Regulatory Submission Expertise: Proven experience preparing and submitting regulatory filings to the FDA, EU MDR, and other global regulatory agencies. Experience with Class II and Class III device submissions in US and EU required.