Principal Regulatory Affairs Specialist
Medtronic(1 month ago)
About this role
A Principal Regulatory Affairs Specialist at Medtronic supports the development and implementation of long-range regulatory strategies for ENT products, ensuring compliance with U.S. and applicable international requirements. The role serves in a leadership capacity, mentoring regulatory staff and assisting management with regulatory planning across the product lifecycle. It also contributes to cross-business regulatory coordination and supports regulatory aspects of acquisitions.
Required Skills
- Regulatory Strategy
- Submission Preparation
- FDA Regulations
- CE Marking
- 510(k) Submissions
- PMA Submissions
- Labeling Review
- Change Control
- Due Diligence
- Project Management
+3 more
Qualifications
- Bachelor’s Degree
- Master’s Degree
About Medtronic
medtronic.comPeople-centered, data-driven, personalized. Solving our world’s biggest health challenges with advanced technology.
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