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PATRICK LEE, M.B.A., M.S., PE, RAC, director of regulatory affairs at BioCardia, Inc., is a regulatory affairs / QA professional with over 25 years of experience in FDA¨Cregulated industries including health-care, medical device, and nutritional products. He formerly served as the senior director of regulatory affairs and quality assurance at Vascular Dynamics, Inc. (VDI). Neuro-implants, cardiovascular devices, laser devices, cell therapy biologics, blood processing and stem cell harvesting devices are a few product categories he has worked in.