Jay Vaishnav

Speaking Session: Is Your AI Baby Ugly?: What FDA Actually Wants to See in 2026

Jay Vaishnav
Director Regulatory Affairs, Canon Medical Informatics

UCSC Silicon Valley Extension

Jay Vaishnav, Ph.D., RAC-Devices, FRAPS, is a regulatory affairs leader and instructor at UCSC Silicon Valley Extension, bringing over 20 years of experience spanning medical device startups, multinational corporations, academia, and federal agencies.

Dr. Vaishnav’s extensive career includes serving as an FDA regulator, where she gained deep insight into federal oversight, followed by leadership roles guiding high-stakes regulatory strategies for medical devices—with a particular emphasis on AI-enabled and software-based technologies. She currently serves as Director of Regulatory Affairs at Canon Medical Informatics.

A recognized authority in her field, Dr. Vaishnav is co-editor of Fundamentals of Medical Device Regulations: A Global Perspective, a comprehensive reference featuring contributions from over 70 authors. She is a Fellow of the Regulatory Affairs Professionals Society (RAPS), vice-chair of its Fellows Program, and serves on advisory boards for UCSC Extension's Regulatory Affairs and Medical Device Quality and Design certificate programs. She holds a Ph.D. in physics from Harvard University.