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Steve Lin Location
California, United States
Steve Lin Work
Vice President of Regulatory Affairs and Quality Assurance @ (June 2024 - Present)
Senior Director of Regulatory Affairs @ (January 2022 - June 2024)
Director of Quality Assurance and Regulatory Affairs, Digital Biology Group @ (October 2011 - December 2021)
Director of Regulatory Affairs and Quality Assurance @ (April 2008 - October 2011)
Director of Regulatory Affairs and Quality Assurance @ (May 2007 - April 2008)
Quality Manager @ (September 2006 - May 2007)
Quality Manager @ (September 2005 - October 2006)
Steve Lin Education
Illinois
Bachelors (Computer Engineering)
1997-2001
Steve Lin Skills
21 CFR
21 CFR Part 11
Adverse Event Reporting
CAPA
CE marking
CQA
Combination Products
Coronavirus (COVID-19)
Corrective Actions
Corrective and Preventive Action (CAPA)
Cybersecurity
Data Analysis
Design Control
Drug
Emergency Use Authorization (EUA)
FDA
GMP
ISO
ISO 13485
ISO 14971
ISO Standards
Manufacturing
Medical Devices
PMA
Quality Assurance
Quality Control
Quality System
R&D
Regulatory Affairs
Regulatory Filings
SOP
Standard Operating Procedure (SOP)
Testing
U.S. Food and Drug Administration (FDA)
V&V
Validation
Verification and Validation (V&V)
Steve Lin Summary
Steve Lin, based in California, United States, is currently a Vice President of Regulatory Affairs and Quality Assurance at Kohler Ventures. Steve Lin brings experience from previous roles at Coherus BioSciences, Bio-Rad Laboratories, ICAD and U-Systems, Inc.. Steve Lin holds a 1997 - 2001 Bachelors in Computer Engineering @ Illinois. With a robust skill set that includes 21 CFR, 21 CFR Part 11, Adverse Event Reporting, CAPA, CE marking and more. Steve Lin has 1 emails on RocketReach.
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