Kathryn Simpson
Vice President, Regulatory Affairs at Endologix
- Role
- Vice President Regulatory Affairs at Endologix LLC
- Location
- Orange County, CA, US
- LinkedIn followers
- 500 followers
About Kathryn Simpson
Seasoned regulatory affairs leader with history of progressive responsibility in regulatory strategies and submissions. Experience includes PMAs (originals, supplements, and FDA panel meetings), IDEs, 510(k)s, EU technical documentation, design controls, change controls, and promotional requirements.
Experience
Vice President Regulatory Affairs
Sep 2024 — Present · Irvine, CA, US
Education
Rice University
Ph.D., Bioengineering
1999 — 2004
University of Memphis
B.S., Electrical Engineering
1995 — 1999
Skills
- Fda
- Medical Devices
- Clinical Research
- Capa
- Design Control
- Product Launch
- Quality System
- V&V
- Biomedical Engineering
- Validation
- Clinical Trials
- Regulatory Requirements
- Ce Marking
- Regulatory Affairs
- Cross-Functional Team Leadership
- Iso 14971
- Iso 13485
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