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.
About
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 Fundamentals of Medical Device Regulations: A Global Perspective, 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 UCSC Silicon Valley Extension Regulatory Affairs and Medical Device Quality and Design certificate programs.
