Russ Pagano

VP, Quality & Regulatory Affairs at Enable Injections

Russell Pagano, Ph.D., has over 28 years of regulatory affairs experience in various sectors including start-ups, the FDA, consulting, medical device, and pharma. At Enable Injections, he leads both the quality and regulatory teams, which includes responsibility for the regulatory submission and approval efforts for the enFuse®. Prior to Enable Injections, Dr. Pagano was the Global Regulatory Lead for Baxter Healthcare’s Advanced Surgery business unit. In this role, he led a team in gaining approval for new products and geographical expansion as well as supporting renewals for an approximately one-billion-dollar portfolio which included multiple combination biologic/device applications. Prior to Baxter, Dr. Pagano held positions covering urological, neurological, orthopedic, and cardiovascular devices at the FDA Office of Device Evaluation. After the FDA, he co-founded a regulatory and clinical consulting company, MSquared Associates, in the DC area, where he served as a consultant for a variety of medical device firms until he left to become Vice President of Clinical and Regulatory Affairs at BioMimetic Therapeutics, a medical device start-up company.

Russ earned a Bachelor of Science, Master of Science, and Doctor of Philosophy in Mechanical Engineering and Materials Science from Duke University.

Timeline

  • VP, Quality & Regulatory Affairs

    Current role

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