Justin Eggleton

Justin Eggleton

Senior Director, Spine Regulatory Affairs
Background

Mr. Eggleton is skilled at leveraging expertise in biomechanics, biomaterials, and regulatory science to manage regulatory projects for device categories, which have included: total disc replacements, interspinous spacers, nucleus replacements, facet replacements, posterior dynamic stabilization systems, kyphoplasty/vertebroplasty, bone void fillers, spine navigation systems, and spinal fusion instrumentation. 

Mr. Eggleton served as a lead reviewer in the FDA Orthopedic Devices Branch, and contributed to the development of guidance and documents and ASTM technical committees regarding orthopedic device testing. Mr. Eggleton has extensive knowledge of medical device regulations and is adept at creating regulatory strategies and pathways for bringing innovative, life-changing spinal technologies to market. 

Education

Mr. Eggleton received a Bachelor of Science degree in Biomedical Engineering from Drexel University. 

Experience

Mr. Eggleton has significant experience in drafting, preparing, and submitting FDA filings including 510(k) pre-market notifications, investigational device exemptions (IDE), and pre-market approvals (PMA), De Novo applications and pre-submissions. 

Overview

Mr. Eggleton is responsible for regulatory affairs relevant to the spine devices for MCRA clients, with experience writing FDA submissions and drafting test protocols. He also develops regulatory strategies for unique indications, device designs, or materials.  

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