Melanie Vincent
Happily Retired😁
- Role
- Senior Director of Regulatory Affairs at Medtronic
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
Experience
Senior Director of Regulatory Affairs
Feb 2013 — Present
Lead the Pre Market Regulatory groups to provide Regulatory strategies to the Development teams on timely product approvals worldwide. Extended team member to 3 General Managers that each lead a different therapy within the Medtronic Cardiac Rhythm Disease Management Business; Brady, Tachy and Heart Failure.
Education
University of St. Thomas
MBA, Business
1988 — 1995
Skills
- U.s. Food and Drug Administration (Fda)
- Quality System
- Clinical Trials
- Fda
- Cross-Functional Team Leadership
- Iso 14971
- R&D
- Design Control
- Pma
- Regulatory Affairs
- Validation
- Regulatory Submissions
- Commercialization
- Medical Devices
- Capa
- Iso 13485
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