Sr. Principal Regulatory Affairs Strategy Specialist
Core
Sr. Principal Regulatory Strategy Specialist shaping and advancing global regulatory strategies for complex medical devices, novel technologies, and software-enabled products across the product lifecycle. (via careerplan.io/jobs/R76748-1-sr-principal-regulatory-affairs-strategy-specialist-at-medtronic)
Role type
Sr. Principal Regulatory Strategy Specialist (IC)
Builds
Enterprise regulatory strategies, risk-based pathways, and educational content for operating unit teams.
Domain
Healthcare / Medical Devices / Regulatory Affairs
Required skills
Global regulatory strategy, M&A regulatory due diligence, software/AI device regulation, regulatory authority interaction, risk management, post-market commitments, regulatory intelligence synthesis, strategic recommendations
Preferred skills
Global regulatory pathways for high-risk/novel tech, health authority submission support, software lifecycle management, M&A integration advisory, regulator review experience, training content development, analytical judgment, cross-functional influence, product development knowledge, RAC certification
Technologies
Software-enabled medical devices, AI-enabled functionality, connected systems, interoperability
Responsibilities
Partner with operating unit teams to develop strategies for complex devices and novel technologies; Provide strategic input on regulatory pathways, intended use, claims, and evidence; Support regulatory authority interactions and briefing materials; Advise on software and digital-health regulatory strategy; Serve as enterprise advisor for M&A and integration activities; Translate global regulatory trends into business implications; Identify strategic issues to inform training content; Synthesize complex issues into recommendations for senior leaders.
Seniority
Principal, strategy & mentorship