Jay Vaishnav
Director Regulatory Affairs, Canon Medical Informatics
Regulatory affairs is a mix of art and science. The science is building and testing solid technology; the art is in making strategic decisions, communicating, and creatively balancing business needs and regulatory requirements. In class, I hope to teach you some of the art.
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JAY VAISHNAV, Ph.D., RAC-Devices, FRAPS, is an industry regulatory affairs leader and former FDA regulator with deep experience leading and negotiating high-stakes FDA interactions for medical devices, including AI-enabled and software-based technologies. She brings more than 20 years of experience across startups, multinational corporations, academia, and federal agencies including the FDA and NIST.
Vaishnav is co-editor of , a widely used industry reference with over 70 authors. She is a fellow of the Regulatory Affairs Professional Society and the vice-chair of the Fellows Program. She holds a doctorate in physics from Harvard University.
In addition to teaching, Vaishnav serves on the advisory boards for °®¶¹´«Ã½ Silicon Valley Extension Regulatory Affairs and Medical Device Quality and Design certificate programs.
