2021 -2023 VP, Regulatory Affairs and Quality Assurance @
2019 -2021 RAQA Executive, Regulatory Affairs and Life Sciences Quality Compliance @
2017 -2019 Global Regulatory Affairs Program Manager at Watson Health Imaging @
2013 -2017 Regulatory Affairs Director @
2006 -2013 Regulatory Manager @
2003 -2006 Master Black Belt @
1999 -2003 Compliance and Regulatory Manager @
1997 -1999 Black Belt @
1995 -1997 Quality Leader @
1994 -1995 Quality Engineer @
1992 -1994 Quality Engineer @
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 4 mobile phone numbers on RocketReach.
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