Principal Regulatory Strategy Specialist

Responsibilities

• 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 identifying 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.

• 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.
• Experience developing or advising on global regulatory strategies, pathways, and evidence approaches for complex, high‑risk, or novel technologies.
• Experience supporting medical device submissions and health authority interactions.
• Working knowledge of software and AI‑enabled medical devices.
• 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.
• Strong analytical judgment, with the ability to balance business objectives, regulatory requirements, patient impact, and execution risk.
• Strong collaboration and influence skills, with the ability to build trust across businesses, functions, and geographies.
• Knowledge of product development, clinical strategy, quality systems, manufacturing, and post‑market requirements for medical devices.
• Advanced degree in a technical, scientific, or engineering area; RAC certification or similar credential is a plus.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.