Debbie Peacock
Retired at None
- Role
- Senior Manager Regulatory Affairs at Hologic, Inc.
- Location
- Myrtle Beach, US
- LinkedIn followers
- 500 followers
OperationsView LinkedIn profile
Experience
Senior Manager Regulatory Affairs
Apr 2015 — Present · danbury, CT, US
Work on submissions and support for Hologic\'s women\'s health products in U.S, EU and rest of world. Submit 510(k) and PMAs for memmography and CAD products.
Education
State University of New York College at Potsdam
BA, English
1916 — 2022
Skills
- Sop
- Fda
- Biomedical Engineering
- U.s. Food and Drug Administration (Fda)
- Regulatory Requirements
- Design Control
- Regulatory Affairs
- Hardware Diagnostics
- Corrective and Preventive Action (Capa)
- 21 Cfr Part 11
- Quality System
- Iso 13485
- Cross-Functional Team Leadership
- Iso 14971
- Software Documentation
- Validation
- Medical Devices
- Capa
- Premarket Approval (Pma)
- Change Control
- Quality Assurance
- V
- Pma
- Gmp
- Regulatory Submissions
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