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Antoanela Gomard

Senior Director, Quality and Regulatory Affairs

Antoanela has two decades of experience in the medical device sector in fields such as cardiovascular, ENT, medical wearable devices, medical imaging, including leadership roles at companies ranging from small start-ups to those among the Fortune 500.

 

Prior to joining Exo, Antoanela was the owner of Medical Device Advantage LLC, a consulting business providing quality, regulatory, operations and program management services to medical device start-ups. During her career, she fulfilled leadership positions at companies such as Abbott Laboratories, Acclarent, and Johnson & Johnson. Antoanela has been instrumental in the launch of multiple products and in regulatory approvals for Class II and III medical devices in the U.S. and abroad. She is an expert in developing Quality Systems, a Lead Auditor for ISO 13485, and a Six Sigma Black Belt.

 

Antoanela earned her B.S. and M.S. in Mechanical Engineering and Ph.D. in Industrial Engineering from the Polytechnic University of Bucharest, Romania.