Caroline Rhim, PhD
Caroline brings over 20 years of experience in the medical device and life sciences field and provides strategic and hands-on consulting services for clients looking to develop and market innovative medical devices. She is an expert in navigating the U.S. regulatory landscape, developing efficient regulatory strategies, and tackling challenging premarket submissions.
She previously led the North America Medical Device consulting team at NSF International, where she served in a cross-functional role for the global business unit. Prior to consulting, Caroline was 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 in the former Office of Device Evaluation (ODE, now OPEQ).
Meaghan Bailey
Meaghan Bailey has over 15 years’ experience developing regulatory strategies and submissions on behalf of device manufacturers seeking US marketing authorization for their novel products. Her expertise includes devising effective regulatory pathways and submissions for Class II and III medical devices, providing regulatory input to cross-functional teams during product development, resolving FDA questions on behalf of a sponsor, and supporting FDA meetings (including preparation for Advisory Committee Panel meetings).
Meaghan was previously an Executive Director at NSF International in their Medical Devices practice, with a focus on bringing new devices through the FDA review process. Prior to that, she was a Managing Director at Becker & Associates Consulting, a boutique device/pharma regulatory consulting firm in Washington, DC.