Our Team

Karen Wu

Director of Regulatory Affairs at CKI

Karen is a RAPS certified regulatory professional with over 17 years of experience in regulatory affairs and quality compliance in the medical devices industry. Prior to joining ClaroNav Kolahi, Karen has held various leadership roles focusing on regulatory submissions and strategic planning across international jurisdictions.

Karen is a certified QMS auditor via Exemplar Global-BSI, and has a HonB.S from the University of Toronto in Biology, and a M.S. from Johns Hopkins University in Regulatory Science.