Nancy Isaac

Nancy has over 25 years of experience in the regulated industry including basic research, regulatory affairs, quality assurance, corporate compliance and clinical research. She has worked and consulted on projects including medical devices, drugs, combination products, IVDs and biologics, in various therapeutic areas. Nancy is currently the Vice President of Regulatory, Quality and Clinical Affairs at Cardiokinetix, where she has been since 2014. Prior to that, she was the Vice President of Clinical Affairs, Regulatory Affairs and Quality at NeoTract, Inc. There she successfully led the clinical IDE study and De Novo for the Urolift System. Amongst many other regulatory positions, she was also the World Wide VP of Regulatory and Quality for BD Biosciences. Nancy holds a B.S. in Cell and Molecular Biology from San Francisco State University, a J.D. from Boston University School of Law with a concentration in Health Law as well as a Masters in Public Health and Law from Harvard School of Public Health. She is a member of the California Bar. Nancy has also lectured and taught at Santa Clara Law School, Haas School of Business, Stanford Medical School and UC Santa Cruz.