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Gina Shih

Senior Director, RA/QA, North Asia @ C.R. Bard

Gina Shih Contact Details

New Providence, New Jersey
Senior Director, RA/QA, North Asia @ C.R. Bard
Director, Regulatory Affairs @ Davol, Inc. A division of C.R. Bard
Director, Regulatory Affairs @ Exactech
BS, Agriculture @ University of Florida

Languages: English and Mandarin Chinese Specialties: U.S. regulatory in medical device and pharmaceutical fields - Class II and III medical device regulations, PMA supplements, 510(k), Pre-IDE, IDE, ANDA, annual report, registration and listing, MDR reporting, internal audit, regulatory / commercial strategies, regulatory compliance, direct FDA interactions including supervisory oversight and ombudsman process, labeling and promotional materials. International 

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