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Michael Willingham Location
Seattle, WA, US
Michael Willingham Work
2025 -now Head of Regulatory Compliance @
2023 -now Affiliate Associate Professor @
2016 -2020 Vice President, Regulatory Affairs and Quality Assurance @
2020 -2024 Director, Regulatory Affairs, Google Health at Google @
2012 -2016 VP, Quality Assurance and Regulatory Affairs @ Caradigm
2006 -2012 Sr. Director, Quality and Regulatory @
2004 -2006 VP, International Business Operations @ Medtronic Physio-Control
1995 -2004 VP, Quality and Regulatory @ Medtronic Physio-Control
Michael Willingham Education
University of Mississippi
BSEE
1980-1982
University of Washington
Engineering
Michael Willingham Skills
Medical Devices
ISO 13485
FDA
Regulatory Affairs
Design Control
Quality System
CAPA
GMP
Healthcare
Quality Assurance
V&V
Quality Management
ISO 14971
Leadership
Validation
Cross-functional Team Leadership
Healthcare Information Technology
Six Sigma
Biomedical Engineering
Lean Manufacturing
Emotional Intelligence
21 CFR Part 11
Quality Auditing
Supplier Quality
ISO
FMEA
Change Control
Development
Auditing
Verification and Validation V&V
Regulatory
Web Services
Cross Functional Team Leadership
Manufacturing
u.s. Food and Drug Administration Fda
Software Development
ISO Standards
Services
u.s. Food and Drug Administration
Verification and Validation
Michael Willingham Summary
Michael Willingham, based in Seattle, WA, US, is currently a Head of Regulatory Compliance at KardioGenics,Inc. Michael Willingham brings experience from previous roles at School Of Pharmacy University Of Washington, 98point6 Inc., Google and Caradigm. Michael Willingham holds a 1980 - 1982 BSEE @ University of Mississippi. With a robust skill set that includes Medical Devices, ISO 13485, FDA, Regulatory Affairs, Design Control and more. Michael Willingham has 3 emails and 3 mobile phone numbers on RocketReach.
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