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Michael Willingham Location
Seattle, WA, US
Michael Willingham Work
Head of Regulatory Compliance @ (September 2025 - Present)
Affiliate Associate Professor @ (April 2023 - Present)
Director, Regulatory Affairs, Google Health at Google @ (June 2020 - November 2024)
Vice President, Regulatory Affairs and Quality Assurance @ (October 2016 - June 2020)
VP, Quality Assurance and Regulatory Affairs @ Caradigm (June 2012 - September 2016)
Sr. Director, Quality and Regulatory @ (January 2006 - June 2012)
VP, International Business Operations @ Medtronic Physio-Control (January 2004 - December 2006)
VP, Quality and Regulatory @ Medtronic Physio-Control (January 1995 - December 2004)
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, Google, 98point6 Inc. 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 4 mobile phone numbers on RocketReach.
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