2018 -2019 Review Leader, Advertising and Promotion, Regulatory Affairs @
2017 -2018 Consultant, Regulatory Affairs @
2016 -2017 Manager, Regulatory Affairs @
2014 -2016 Principal Associate, Regulatory Affairs @
2009 -2014 Specialist, Regulatory Affairs @
Lin Wu Education
The Johns Hopkins University
Master of Science
Hood College
Master of Science (Biotechnology)
Jilin University
(Medicine)
Lin Wu Skills
GMP
Regulatory Affairs
Regulatory Submissions
Design Control
Biotechnology
IND
Clinical Trials
Cross Functional Team Leadership
FDA
Medical Devices
CE marking
ISO 14971
Regulatory Requirements
Quality System
PMA
ISO 13485
Biomedical Engineering
21 CFR
21 CFR Part 11
CAPA
eCTD
V&V
Validation
u.s. Food and Drug Administration
Lin Wu Summary
Lin Wu, based in Brunswick, ME, US, is currently a Associate Director, Commercial Regulatory Affairs at Supernus Pharmaceuticals, Inc.. Lin Wu brings experience from previous roles at Ge Healthcare, Treximo, Depuy Synthes Companies and Fresenius Medical Care North America. Lin Wu holds a Master of Science @ The Johns Hopkins University. With a robust skill set that includes GMP, Regulatory Affairs, Regulatory Submissions, Design Control, Biotechnology and more. Lin Wu has 1 emails on RocketReach.
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