Caroline Rhim

Speaking Session: Your Pre-Sub Is Not Therapy: How to Get Useful Answers From FDA

Caroline Rhim
Principal Consultant

Evera Regulatory Advisors, LLC

Caroline Rhim, PhD, is a regulatory consultant and an advisor to Bluestocking Health, bringing over two decades of experience guiding global consulting teams and helping medical device innovators translate complex regulations into actionable roadmaps.

Prior to consulting, Dr. Rhim served at the U.S. Food and Drug Administration (FDA) within the Center for Devices and Radiological Health (CDRH). During her time at the agency, she was Chief of the Anterior Spine Devices Branch and worked as a lead scientific reviewer for premarket submissions across the orthopedic and cardiovascular groups in the former Office of Device Evaluation (ODE, now OPEQ). In the consulting sector, she previously served as a Managing Director at Becker & Associates Consulting, a boutique medical device and pharmaceutical regulatory firm based in Washington, D.C.

Today, through Evera Regulatory Advisors and her advisory work, Dr. Rhim collaborates with companies of all sizes, combining science, technology, and regulatory strategy to help innovators successfully navigate premarket submissions, overcome agency hurdles, and bring emerging medical technologies to market.