Senior Regulatory Affairs Specialist
Medtronic(27 days ago)
About this role
The Senior Regulatory Affairs Specialist supports R&D programs in Coronary and Renal Denervation, developing pre-market global regulatory strategies and preparing worldwide submissions for medical devices including software/SaMD and AI components. Based in Mounds View, MN or Santa Rosa, CA, the role supports US and international filings and compliance while working on-site most of the week.
Required Skills
- Regulatory Strategy
- Regulatory Submissions
- SaMD
- AI
- Cybersecurity
- Labeling Review
- Agency Negotiation
- QMS Audits
- ISO 13485
- ISO 14971
+4 more
Qualifications
- Bachelor’s Degree in a Technical Discipline
- Master’s Degree (Preferred)
About Medtronic
medtronic.comPeople-centered, data-driven, personalized. Solving our world’s biggest health challenges with advanced technology.
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