Caroline Rhim

Caroline Rhim, Ph.D.

Medical Devices and IVD Consulting

Caroline Rhim brings over 10 years of experience in the medical device and public health sectors to NSF International, where she focuses on providing strategic and hands-on consulting services for clients looking to develop and market innovative medical devices. Dr. Rhim is an expert in navigating the U.S. regulatory landscape, tackling challenging premarket submissions and developing efficient regulatory strategies. Prior to joining NSF International, she served as Chief of the Anterior Spine Devices Branch at the FDA’s Center for Devices and Radiological Health (CDRH). She was also a lead scientific reviewer for premarket submissions (premarket approval (PMA), 510(k) premarket notification, investigational device exemption (IDE) submissions, etc.) in both the Divisions of Orthopedic Devices and Cardiovascular Devices. During her career at the FDA, she was involved in streamlining premarket and postmarket review processes as well as the classification efforts for posterior cervical screw systems. Dr. Rhim received Bachelor and Master of Science degrees in materials science and engineering from MIT and a doctorate in biomedical engineering from Duke University.