Elsa Abruzzo

Regulatory Advisor at Intralink-Spine

Elsa Abruzzo's experience spans a 25+ year successful regulatory, quality, clinical, and operations track record. As Founder and CEO of Cygnus Regulatory, her areas of expertise include cardiovascular, neurovascular, orthopedic, CRM, diagnostic imaging, mHealth, Health IT, and point of care diagnostics.

Prior to Cygnus, Ms. Abruzzo worked at companies such as Baxter, Cordis JNJ, CryoLife, Percutaneous Valve Technologies (acquired by Edwards Lifesciences), AtriCure, and Polymer Technology Systems Cardiochek.

Ms. Abruzzo’s regulatory strategies have resulted in the global commercialization of numerous technologies. Some of the disruptive medical solutions Elsa helped bring to market include transcatheter tissue heart valves, implantable biomaterials, surgical adhesives, embolic agents, stents, atrial fibrillation ablation devices, and neuromodulation devices, and point of care analyzers.

Ms. Abruzzo has a B.S. in engineering from the University of Miami (Coral Gables, FL), is regulatory affairs certified (RAC), and a Fellow of the Regulatory Affairs Professional Society (FRAPS) Fellow.

Timeline

  • Regulatory Advisor

    Current role