Overview In this role, you shape regulatory strategies for complex medical devices and novel technologies within Global Regulatory Affairs. You'll partner with operating unit teams to anticipate obstacles, evaluate pathways, and guide due diligence for acquisitions, including software-enabled products. You work with cross-functional partners to translate evolving regulations into actionable plans, acting with independence and influencing enterprise-wide decisions. The position emphasizes collaboration, regulatory expertise, and practical guidance across product lifecycles in a patient-first, fast-paced environment.
Compensation / Benefits- Health, dental and vision insurance
- Health Savings Account
- 401(k) plan with employer match
- Employee Stock Purchase Plan
- Tuition assistance/reimbursement
- Simple Steps well-being program
Responsibilities- Partner with operating unit regulatory teams to develop and refine strategies for complex medical devices, novel technologies, and market expansion opportunities
- Provide strategic input on regulatory pathways, intended use, evidence expectations, risk management, and post-market commitments
- Support regulatory authority interactions by framing key questions, reviewing briefing materials, and contributing to response strategies
- Advise on software and digital-health regulatory strategy, including software lifecycle management, AI-enabled functionality, and interoperability
- Serve as enterprise advisor on M&A, integration, or remediation activities by identifying regulatory opportunities and risks
- Translate regulatory intelligence into practical implications for Medtronic business regulatory strategies
- Identify recurring strategic issues and deficiency trends to inform training content
- Synthesize complex technical and regulatory issues into clear recommendations for leaders and cross-functional partners
Key requirements- Bachelor's degree
- 10+ years of related experience within the medical device industry or a regulatory agency (or 8+ years with an advanced degree)
- Strong collaboration and influence skills
- Analytical judgment
- Ability to balance business objectives, regulatory requirements, and patient impact
- Knowledge of software and AI-enabled medical devices including software lifecycle management, documentation, risk management, validation, maintenance, and change control
- Experience supporting medical device submissions and health authority interactions
- Regulatory input for M&A, licensing, or integration activities
