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Ms. Lopez brings over 20 years of regulatory/clinical affairs/quality assurance experience in medical devices and pharmaceuticals companies. Her experience includes US and international regulations related to clinical trials/premarket submissions (PMA, IDE, 510k, MDD/IVDD) and quality systems (FDA QSR, ISO), as well as activities related to strategic planning, contract manufacturing, and mergers/acquisitions. Ms. Lopez served as Vice President, Regulatory & Quality Assurance for Novatrix Biomedical, Director of Clinical Affairs at Micro Therapeutics, and Director of Regulatory Affairs at Cryogen. Ms. Lopez holds a B.S. in chemical engineering from the Philippines, and a MS in operations research from Stanford University. | 