Tracey Fox
Vice President Regulatory Affairs @ Olympus Corporation | Medical Devices, US-RAC
- Role
- Vice President Regulatory Affairs at Olympus Corporation
- Location
- Waukesha, WI, US
- LinkedIn followers
- 500 followers
About Tracey Fox
Tracey has an extensive background in quality and regulatory affairs, with qualifications including Six Sigma Master Blackbelt, Lead Quality System Auditor, Certified Quality Engineer, and US Regulatory Affairs Certification (RAC). Her educational background includes a bachelor\'s degree in Industrial Engineering from Marquette University, and a Masters in Regulatory Affairs from San Diego State University, where her thesis focused on Internet Advertising of Medical Devices.
Experience
Vice President Regulatory Affairs
Apr 2023 — Present
Education
Marquette University
Bachelors, Industrial Engineering
1988 — 1992
San Diego State University
Masters, Regulatory Affairs
2006 — 2009
Skills
- Change Control
- Six Sigma
- Gxp
- Quality Auditing
- U.s. Food and Drug Administration (Fda)
- Cqa
- Quality Management
- Iso
- Sop
- Fda
- Medical Devices
- Capa
- Iso 13485
- 21 Cfr Part 11
- Regulatory Affairs
- Quality System
- V&V
- Root Cause Analysis
- Validation
- Ce Marking
- Auditing
- Dmaic
- Regulatory Submissions
- Medical Device Directive
- Design Control
- 21 Cfr
- Regulatory Requirements
- Quality Assurance
- Cross-Functional Team Leadership
- Iso 14971
- Fmea
- Product Development
- Fda Gmp
- Gmp
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