Senior Vice President, Regulatory Affairs and Quality Assurance @ (January 2024 - April 2024)
Senior Vice President, Regulatory Affairs and Compliance @ (May 2019 - March 2023)
Vice President, Quality, Regulatory and Clinical Affairs @ (July 2015 - May 2019)
VP, Quality Assurance and Regulatory Affairs @ (October 2011 - July 2015)
VP Quality Assurance @ (March 2006 - October 2011)
Vice President, Quality Assurance @ (April 2003 - October 2011)
Global VP, Quality Assurance @ Covidien Respiratory and Monitoring Solutions (April 2006 - October 2011)
Mike Spears Education
Darla Moore School of Business at the University of South Carolina
MBA (Business)
1995-1998
University of Tennessee, Knoxville
BA
1982-1987
Mike Spears Skills
21 CFR Part 11
CAPA
Corrective and Preventive Action (CAPA)
Cross-functional Team Leadership
DMAIC
Design Control
FDA
GMP
ISO 13485
ISO 14971
Leadership
Medical Devices
Quality Assurance
Quality System
R&D
Regulatory Affairs
Research and Development (R&D)
Root Cause Analysis
Six Sigma
U.S. Food and Drug Administration (FDA)
U.S. Title 21 CFR Part 11 Regulation
V&V
Validation
Verification and Validation (V&V)
Corrective and Preventive Action Capa
Microsoft Excel
Public Speaking
Pharmaceutical Industry
Verification and Validation V&V
Cross Functional Team Leadership
Research and Development R&d
u.s. Food and Drug Administration Fda
u.s. Food and Drug Administration
Corrective and Preventive Action
Verification and Validation
Research and Development
Mike Spears Summary
Mike Spears, based in United States, is currently a Senior Vice President, Regulatory Affairs and Quality Assurance at Solventum. Mike Spears brings experience from previous roles at 3M, Insulet Corporation and Covidien. Mike Spears holds a 1995 - 1998 MBA in Business @ Darla Moore School of Business at the University of South Carolina. With a robust skill set that includes 21 CFR Part 11, CAPA, Corrective and Preventive Action (CAPA), Cross-functional Team Leadership, DMAIC and more. Mike Spears has 2 emails and 1 mobile phone numbers on RocketReach.
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