Ethan Naylor is a vice president of Regulatory Affairs at MCRA, an IQVIA business. He is focused primarily on U.S. regulatory submissions for spinal medical devices. Naylor helps clients with FDA regulatory strategies and submission support, including pre-submissions for non-clinical and clinical data development, 510(k)s, Breakthrough Device Designations, De Novo classification requests, and premarket approvals. Before joining MCRA, Naylor worked for nearly six years at the FDA, where he was an assistant director, a policy analyst in the 510(k) staff office, and a lead reviewer in the Spine Division. He earned a master of science degree in biomedical engineering from Johns Hopkins University and a bachelor of science degree in biochemistry from Indiana Wesleyan University.