Director Regulatory Affairs, Quality Assurance & Reimbursement pricing
Stryker, East Asia
Leslie Kim is director of Regulatory Affairs, Quality Assurance & Market Access for Stryker East Asia which is cluster covering for Korea, Hongkong, Taiwan & ASEAN countries since Nov. 2019. Prior to that, she has been responsible for Stryker Korea’s RAQA & MA for 12 years.
Leslie has worked with Korea FDA, called MFDS(Ministry of Food & Drug Safety) around 20 years in total for overall process of pre-market approval, post market surveillance and Quality Management System. And she expanded to the role of market access with reimbursement strategy and pricing working with HIRA(Health Insurance Review & Assessment Service) & MOHW(Ministry of Health & Welfare) since 2014.
Prior to joining Stryker, she has worked as Regulatory Affairs manager in Korean local medical device company for 7 years and joined to Stryker in 2007. Leslie earned Bachelor’s degree of Business Management in Hanyang University, and she earned Master degree of Public Health in Yonsei University.
Leslie currently serves on the KMDIA(Korea Medical Device Industry Association) as a core industry member in Reimbursement Committee and Regulatory Affairs Committee. Also, she has worked as a vice chair for Korea COE group of APACMed.