Rhona Shanker is the Head of US Device Regulatory Affairs at Novateur Ventures. She is a regulatory affairs expert and former FDA/CDRH/ODE expert regulatory reviewer, having over 35 years experience in the medical device industry and reviewing over 3,500 applications. Rhona’s professional experience is focused on developing strategies for complying with FDA pre- and post-market regulatory requirements, including: developing regulatory strategies for pre-market submissions; planning IDE, 510(k), PMA, HUD, HDE, and CE projects; and preparing 510(k), IDE, PMA, Design Dossiers, and Clinical Evaluation Reports for submission. Previously, Rhona held a position as the Expert Regulatory Review Scientist for heart assist devices at the FDA’s Center for Devices and Radiological Health (CDRH), in the Office of Device Evaluation (ODE), Division of Cardiovascular and Respiratory Devices (DCRD/DCD). Prior to that, she worked in the positions of Senior Reviewer and Consumer Safety Officer at the FDA. Rhona has been an invited speaker at multiple medical and regulatory affairs affiliated conferences, expositions, and webinars. She graduated from Emory University with a degree in Biology and has co-authored several professional publications.
