Sr. Principal Regulatory Affairs Strategy Specialist

We anticipate the application window for this opening will close on - 22 Sep 2026   Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year.

Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life                     The Sr. 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. 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.

LOCATION: The person in this role may work onsite at a US-based Medtronic facility. 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 10+ years of related experience within the medical device industry or a regulatory ag