Instructor

Jay Vaishnav LinkedIn

"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, an industry regulatory affairs professional and former FDA regulator, has navigated high-stakes negotiations between industry and regulatory agencies from both sides. Her two decades of experience in science and technology have included time at startups, multinational corporations, the FDA, NIST, and academia. She is a lead editor of the forthcoming sixth edition of Fundamentals of Medical Device Regulations, a widely respected reference in the industry. She holds a doctorate in physics from Harvard University.

Associated Program(s)

Regulatory Affairs

Communicating and Negotiating with the FDA