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Mike O'Hara

Regulatory Affairs, Combination Products @ W. L. Gore & Assoc.

Mike O'Hara Contact Details

Flagstaff, Arizona
Regulatory Affairs, Combination Products @ W. L. Gore & Assoc.
Regulatory Affairs, BioPharmaceutical Products @ W. L. Gore & Assoc.
Research & Development Project Management @ W. L. Gore & Assoc.
Bachelor of Science (BS) @ University of California, Santa Barbara

Accomplishments Regulatory Affairs: -Created technical file dossiers to support CE mark of Class III medical devices -Managed consultants in support of international regulatory assessments -Created Type 3 Drug Master Files for Pharmaceutical and Biologics Packaging and Drug Delivery -Created PMA in-vitro modules and provided technical defense of PMA submissions -Implemented External Standards Assessment Process and procedure to 

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