Tracey Fox Email & Phone Number
Vice President Regulatory Affairs @ Olympus Corporation
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Tracey Fox Location
- Waukesha, WI, US
Tracey Fox Work
- Vice President Regulatory Affairs @ (April 2023 - Present)
- VP, Regulatory Affairs and Quality Assurance @ (September 2021 - April 2023)
- RAQA Executive, Regulatory Affairs and Life Sciences Quality Compliance @ (June 2019 - August 2021)
- Global Regulatory Affairs Program Manager at Watson Health Imaging @ (September 2017 - June 2019)
- Regulatory Affairs Director @ (April 2013 - September 2017)
- Regulatory Manager @ (January 2006 - April 2013)
- Master Black Belt @ (January 2003 - January 2006)
- Compliance and Regulatory Manager @ (January 1999 - January 2003)
- Black Belt @ (January 1997 - January 1999)
- Quality Leader @ (January 1995 - January 1997)
- Quality Engineer @ (January 1994 - January 1995)
- Quality Engineer @ (January 1992 - January 1994)
Tracey Fox Education
- San Diego State University
Masters (Regulatory Affairs)
2006-2009 - Marquette University
Bachelors (Industrial Engineering)
1988-1992
Tracey Fox Skills
- Medical Devices
- Product Development
- ISO 13485
- Design Control
- CAPA
- FDA
- Regulatory Affairs
- CE marking
- Quality System
- ISO 14971
- Regulatory Submissions
- V&V
- GMP
- Quality Auditing
- Validation
- Regulatory Requirements
- Sop
- Quality Management
- Medical Device Directive
- CQA
- Six Sigma
- Quality Assurance
- Cross-functional Team Leadership
- Root Cause Analysis
- DMAIC
- Auditing
- FMEA
- 21 CFR
- Change Control
- 21 CFR Part 11
- ISO
- FDA GMP
- GxP
- Testing
- Materials
- Regulatory
- u.s. Food and Drug Administration Fda
- Strategic Planning
- Training
- Public Speaking
- Cross Functional Team Leadership
- Fox
- Research
- Corrective And Preventive Action Capa
- u.s. Food and Drug Administration
- Corrective and Preventive Action
Tracey Fox Summary
- Tracey Fox, based in Waukesha, WI, US, is currently a Vice President Regulatory Affairs at Olympus Corporation of the Americas. Tracey Fox brings experience from previous roles at Optum, IBM and GE Healthcare. Tracey Fox holds a 2006 - 2009 Masters in Regulatory Affairs @ San Diego State University. With a robust skill set that includes Medical Devices, Product Development, ISO 13485, Design Control, CAPA and more. Tracey Fox has 5 mobile phone numbers on RocketReach.
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