Sr. Principal Regulatory Affairs Strategy Specialist
Skills
About the role
This is a senior principal individual-contributor role at Medtronic within Global Regulatory Affairs, advising on regulatory strategy across the company's device portfolio. You'll partner with operating unit teams on complex regulatory questions, including software and AI-enabled products, and support due diligence for acquisitions, working onsite at a US-based facility at least 4 days a week. It suits an experienced regulatory affairs professional with medical device industry or regulatory agency background.
What you’ll do
- Partner with operating unit regulatory teams to develop strategies for complex and novel technologies
- Provide strategic input on regulatory pathways, claims, evidence expectations, and risk management
- Support regulatory authority interactions including briefing materials and response strategies
- Advise on software and digital-health regulatory strategy, including AI-enabled functionality
- Serve as enterprise advisor to teams conducting M&A, integration, or remediation activities
- Translate evolving global regulations and guidance into practical business implications
- Identify recurring strategic issues and deficiency trends to inform training content
- Synthesize complex technical and regulatory issues into recommendations for senior leaders
What they’re looking for
- Bachelor's degree
- 10+ years of related experience in the medical device industry or a regulatory agency, or 8+ years with an advanced degree
Nice to have
- Experience advising on global regulatory strategies for complex 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 on mergers, acquisitions, or licensing activities
- Direct experience working for a regulator in a scientific review role
- Advanced degree in a technical, scientific, or engineering area
- RAC certification or similar credential
What’s on offer
- Salary range of $157,600 - $236,400 per year
- Eligible for the Medtronic Incentive Plan (MIP)
- Health, dental, and vision insurance
- 401(k) plan with employer contribution and match
- Employee Stock Purchase Plan
- Paid time off and paid holidays
Questions about this role
Is this role remote?
No, it requires a minimum of 4 days a week onsite at a US-based Medtronic facility.
How much does it pay?
$157,600 to $236,400 per year, plus eligibility for the Medtronic Incentive Plan.
How many years of experience are required?
10+ years of related experience, or 8+ years with an advanced degree.
When does the application window close?
The posting anticipates the application window closing on 22 Sep 2026.
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