Hiring: Sr. Principal Regulatory Affairs Strategy Specialist Company: Medtronic Location: Mounds View, MN Job Posted Time: 2026-09-12 13:45:18 Employment Type: On-site Target Skills & Keywords : Risk Management About the job Experience: •10+ years of related experience within the medical device industry or a regulatory agency (or 8+ years with an advanced degree) Required Skills: •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. Qualifications: •The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!