We anticipate the application window for this opening will close on - 26 Jun 2026

 

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 Strategy Specialist is an individual contributor within Global Regulatory Affairs responsible for supporting and partnering with Regulatory teams across the organization as they shape and advance regulatory strategies aligned with Medtronic’s business goals and objectives. This role will partner closely with operating unit teams to provide additional expertise and guidance on complex, novel, and strategically important regulatory questions across the product lifecycle, including supporting effective due diligence for acquisitions. This role will help teams assess options, anticipate obstacles, and develop practical, risk-based pathways for innovative technologies across Medtronic, including but not limited to software-enabled products. The role will also provide consultation to operating unit teams involved in mergers, acquisitions, licensing, and integration activities across product portfolios.

This position is expected to operate with a high degree of independence, influence without direct authority, and convert insights into enterprise value through internal best practices and educational support for regulatory professionals and cross-functional partners. This is a unique opportunity to contribute across Medtronic’s diverse and cutting edge portfolio.

LOCATION: The person in this role may work onsite at a US-based Medtronic facility.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

         

         

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

• Partner with operating unit regulatory teams to help develop and refine strategies for complex medical devices, novel technologies, significant product changes, and market expansion opportunities.
• Provide strategic input on regulatory pathways, intended use, claims, evidence expectations, risk management, and post-market commitments.
• Support regulatory authority interactions by helping frame key questions, review briefing materials, contribute to response strategies, and communicate positions clearly and credibly.
• Advise on software and digital-health regulatory strategy, including software lifecycle expectations, AI-enabled functionality, interoperability, and connected systems.
• Serve as an enterprise advisor to operating unit regulatory teams conducting M&A, integration, or remediation activities by helping identify potential regulatory opportunities, risks, relevant internal process considerations, and applicable cross-portfolio precedent.
• Translate regulatory intelligence regarding evolving global regulations, guidance, policy, and deficiency trends into practical implications for Medtronic business regulatory strategies.
• Identify recurring strategic issues and deficiency trends across operating units to inform training content.
• Synthesize complex technical and regulatory issues into clear recommendations for senior leaders, regulatory teams, and cross-functional partners.

Must Have: Minimum Requirements

• Bachelor's degree
• Minimum of 7 years of experience within the medical device industry or a regulatory agency with a bachelor's degree or a master’s degree with a minimum of 5 years of relevant experience.

Nice to Have (Preferred Qualifications)

• Experience developing or advising on global regulatory strategies, pathways, and evidence approaches for complex, high-risk, or novel technologies where precedent may be limited or evolving.
• Experience supporting medical device submissions and health authority interactions.
• Working knowledge of software and AI-enabled medical devices, including software lifecycle management, documentation, risk management, validation, maintenance, and change control.
• Experience providing regulatory input to teams involved in mergers, acquisitions, licensing, or integration activities.
• Direct experience working for a regulator, particularly in a scientific review role.
• Demonstrated ability to translate changing regulatory expectations into practical internal guidance or educational content.
• Strong an