Senior Regulatory Affairs Manager
BradyKnows Medical, LLC
Tracy Yu is a versatile regulatory and clinical research professional with nearly a decade of expertise and is currently a Senior Regulatory Affairs Manager for BradyKnows Medical, LLC, a China Market Entry Consulting Firm and CRO specializing in medical devices. Tracy's responsibilities include the development of regulatory and clinical strategies and management of pre-market approval projects from planning to completion covering type testing, clinical trials/CER, consultation meeting with China NMPA reviewer, and post-market inspection and China localization projects. She collaborates with medical device manufacturers from all over the world and has worked on a diverse variety of medical devices.
Prior to joining BradyKnows, Tracy worked at multiple global CRO companies in the function of clinical operations, pharmacovigilance, and project management. Tracy earned her Master of Science from Northeastern University in Regulatory Affairs and Master of Science from McGill University in Biotechnology. Tracy has been a frequent speaker/moderator for public webinars and customized training programs for client companies.
Disclosure information not submitted.
Monday, September 12, 2022
9:45 AM – 11:00 AM MST
Tuesday, September 13, 2022
9:45 AM – 11:00 AM MST