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Nancy E. Isaac LinkedIn
"With good tools you can achieve the best possible outcomes with FDA."
NANCY ISAAC, BS, MPH, JD, is a senior management leader and regulatory/clinical/quality advisor with more than 25 years of experience in strategy and obtaining approvals for devices, in vitro diagnostics, drugs, biologics, and combination products for companies. She works with a diversity of organizations, from startups to Fortune 500s in neurology, oncology, orthopedics, urology, cardiology, and pulmonology. She is currently regulatory counsel and vice president of Quality Assurance at Moximed, where she has been since 2017. Prior to that, she was vice president of Clinical Affairs, Regulatory Affairs, and Quality Assurance at NeoTract, Inc. where she successfully led the clinical investigational device exemption (IDE) study and the de novo submission for the Urolift System. Amongst many other regulatory positions, she was also the worldwide vice president of Regulatory Affairs, Compliance, and Quality Affairs for BD Biosciences. Isaac holds a bachelor’s degree in Cell and Molecular Biology from San Francisco State University; a Juris Doctorate from Boston University School of Law with a concentration in Health Law; and a master’s in Public Health and Law from Harvard School of Public Health. She is a member of the California Bar. In addition to teaching, she serves on the UCSC Silicon Valley Extension advisory boards of the Regulatory Affairs and Medical Device certificate programs.