Head of In Vitro Diagnostics and Quality
Gary Riordan is a diagnostic industry veteran with over 20 years of commercialization/regulatory experience. Gary has extensive global regulatory and quality experience, including serving as a primary reviewer at the U.S. Food and Drug Administration (FDA). Gary has held executive positions multiple companies including: iCarbonX, and Nanostring, as Sr. V.P. and V.P. of Quality and Regulatory Affairs. Mr. Riordan also worked at Ventana Medical Systems (a Member of the Roche Group), and at Roche Molecular Systems as Director, Regulatory Affairs. In these positions, he developed regulatory strategies (for IND’s, PLA’s, PMA’s and 510(k)’s) and obtained global diagnostic authorizations that led to the successful launch of assays for the detection and/or quantitation and monitoring of infectious diseases for blood screening and diagnostic use and a major PMA supplement companion diagnostic for cancer. Gary has had successfully initiated and advanced compliant quality systems and has served as the company lead for many successful FDA and ISO audits at multiple companies.