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. Qualifications 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. #J-18808-Ljbffr Jobtailor