Lisa Ewing
- Role
- Sr Regulatory Director at Smith Nephew
- Location
- Pittsburgh, PA, US
- LinkedIn followers
- 500 followers
Manufacturing & ProductionView LinkedIn profile
About Lisa Ewing
Proven regulatory affairs leader with extensive experience in medical device development,…
Experience
Sr Regulatory Director
Sep 2022 — Present
Education
University of Pittsburgh
Bachelor of Science - BS, Electrical Engineering
1996 — 2000
Skills
- Ce Marking
- Iso 13485
- 21 Cfr Part 11
- Fda
- Clinical Trials
- Validation
- V&V
- Medical Devices
- Regulatory Documentation
- Change Control
- Regulatory Affairs
- Clinical Evaluation Reports
- 510(K)
- Regulatory Strategy Development
- Regulatory Submissions
- Design Control
- V
- Regulatory Requirements
- Product Launch
- U.s. Food and Drug Administration (Fda)
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