Faviola Michelot
- Role
- Sr Director, Regulatory Affairs at Edwards Lifesciences
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
General Business & ManagementView LinkedIn profile
Experience
Sr Director, Regulatory Affairs
Apr 2022 — Present
Skills
- V&V
- 21 Cfr Part 11
- Fda
- Validation
- Medical Device Directive
- Regulatory Affairs
- Quality System
- Medical Devices
- 21 Cfr
- Regulatory Requirements
- Iso 13485
- Regulatory Submissions
- Design Control
- Iso 14971
- Capa
- Pma
- Cross-Functional Team Leadership
- Ce Marking
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