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Greg Li Location
Andover, MA, US
Greg Li Work
2024 -now Sr. Regulatory Affairs Manager-MRI @
2022 -2024 Principal Regulatory Affairs Specialist @ Philips Healthcare
2021 -2024 Regulatory program manager, @ Philips Healthcare
2020 -2021 Sr. manager, regulatory @
2015 -2020 Sr. Manager, Regulatory Affairs @
1995 -2005 manufacturing engineering manager and production manager @ Philips Medical Systems/Agilent/HP medical
Greg Li Education
Regis College
Master (Health Product Regulation)
2009-2011
National Tsing Hua University
Bachelor (Mechanical Engineering)
1981-1986
Greg Li Skills
handling audits from EU NB
communication with FDA reviewer
Health Canada license application
Regulatory Strategy Development
technical file/documentation for EU MDD/MDR
510(k)
ISO 13485
FDA
Design Control
CAPA
Medical Device Directive
21 CFR
CE marking
China CFDA
manufacturing control
ISO 14971
Manufacturing
Quality System
Validation
V&V
Medical Devices
Supplier Quality
Quality Auditing
Cross-functional Team Leadership
U.S. Food and Drug Administration (FDA)
Public Speaking
Cross Functional Team
GMP
Regulatory
Regulatory Affairs
Engineering
Cross Functional Team Leadership
U.S. Food And Drug Administration Fda
Management
Product Development
Project Management
u.s. Food and Drug Administration
Greg Li Summary
Greg Li, based in Andover, MA, US, is currently a Sr. Regulatory Affairs Manager-MRI at Philips. Greg Li brings experience from previous roles at Philips Healthcare, Dräger and Philips Medical Systems. Greg Li holds a 2009 - 2011 Master in Health Product Regulation @ Regis College. With a robust skill set that includes handling audits from EU NB, communication with FDA reviewer, Health Canada license application, Regulatory Strategy Development, technical file/documentation for EU MDD/MDR and more. Greg Li has 3 emails and 2 mobile phone numbers on RocketReach.
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