Amy Smith Email & Phone Number
Vice President Regulatory Affairs @ Medtronic
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Amy Smith Location
- Irvine, CA, US
Amy Smith Work
- Vice President Regulatory Affairs @ (January 2025 - Present)
- VP, Global Regulatory Affairs @ (August 2021 - January 2025)
- Vice President, Global Strategic Marketing @ Advanced Sterilization Products (ASP) (June 2017 - August 2021)
- Vice President Regulatory Affairs @ (March 2015 - June 2017)
- Worldwide Director, Regulatory Affairs @ Advanced Sterilization Products (July 2013 - March 2015)
- WW Director, Regulatory Affairs @ (November 2010 - July 2013)
- Director, Product Innovation Regulatory Affairs @ (December 2009 - February 2011)
- Director, Regulatory Affairs @ Animas Corporation (April 2007 - May 2010)
- Manager, RA and Clinical Affairs @ Animas Corporation (July 2005 - April 2007)
- Sr. Regulatory Specialist @ Animas Corporation (March 2005 - July 2005)
- Sr. Regulatory Specialist @ B. Braun Medical (January 2002 - February 2005)
- Product Assurance Engineer @ Ohmeda Medical (July 2000 - December 2001)
Amy Smith Education
- The Johns Hopkins University
MS (Applied Biomedicine)
1999-2002 - Mercer University
BSE (Biomedical Engineering)
1994-1998 - LSMSA 1992-1994
Amy Smith Skills
- 21 CFR
- 21 CFR Part 11
- Biomedical Engineering
- Biotechnology
- CAPA
- CE marking
- Change Control
- Combination Products
- Commercialization
- Corrective and Preventive Action (CAPA)
- Cross-functional Team Leadership
- Design Control
- FDA
- FDA GMP
- GMP
- GxP
- IND
- ISO
- ISO 13485
- ISO 14971
- Manufacturing
- Marketing
- Medical Device Directive
- Medical Devices
- PMA
- Pharmaceutical Industry
- Portfolio Development
- Product Development
- Quality Assurance
- Quality Auditing
- Quality System
- R&D
- Regulatory Affairs
- Regulatory Requirements
- Regulatory Strategy
- Regulatory Submissions
- Research and Development (R&D)
- Standard Operating Procedure (SOP)
- Strategic Planning
- Strategy
- U.S. Food and Drug Administration (FDA)
- U.S. Title 21 CFR Part 11 Regulation
- V&V
- Validation
- Verification and Validation (V&V)
Amy Smith Summary
- Amy Smith, based in Irvine, CA, US, is currently a Vice President Regulatory Affairs at Medtronic. Amy Smith brings experience from previous roles at Terumo Neuro, Advanced Sterilization Products (ASP), Johnson & Johnson and Advanced Sterilization Products. Amy Smith holds a 1999 - 2002 MS in Applied Biomedicine @ The Johns Hopkins University. With a robust skill set that includes 21 CFR, 21 CFR Part 11, Biomedical Engineering, Biotechnology, CAPA and more. Amy Smith has 2 emails and 3 mobile phone numbers on RocketReach.
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