Hangyi Yan

Background

About Hangyi Yan

Dr. Yan has nine years' experience with regulatory affairs, including eight years at FDA (both CDRH and CDER) with medical devices and drugs/biologics. She reviewed and evaluated premarket submissions and used scientific knowledge to recommend and determine sufficient and acceptable studies. Dr. Yan managed programs by providing scientific, regulatory, procedure, and policy guidance and oversight, to ensure program quality and consistency. She managed projects from initiation, planning, executing, monitoring, to closing, to ensure scope, timeline, milestone, and quality. Dr. Yan’s scientific background includes cancer biology, immunology, toxicology, animal studies, cell and molecular biology, and medical devices. She’s strong at self-learning, problem solving, critical thinking, communication, writing, presentation, and working independently and collaboratively.