Kara Johnson
Leader dedicated to helping companies navigate the ever changing regulatory and compliance landscape
- Role
- VP of Regulatory Affairs at Kapstone Medical
- Location
- Manchester, NH, US
- LinkedIn followers
- 500 followers
Manufacturing & ProductionView LinkedIn profile
Experience
VP of Regulatory Affairs
Jun 2024 — Present
Education
Northeastern University
Master's degree, Regulatory Affairs in Drugs, Biologics and Medical Devices
2011 — 2012
Mount Holyoke College
(2) BA, BA in Each: Physics and English
2000 — 2004
Skills
- Medical Devices
- Capa
- Quality System
- Design Control
- Design for Manufacturing
- Design of Experiments
- Electronics
- Fda
- Testing
- Quality Assurance
- Manufacturing
- Root Cause Analysis
- Iso 13485
- R&D
- Regulatory Affairs
- Software Documentation
- Product Development
- Gmp
- Validation
- V&V
- Fmea
- Quality Management
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