George Cusatis MS, RAC

George Cusatis is Director of Merck’s Device & Digital Health team, part of Global Regulatory Affairs & Clinical Safety based in Upper Gwynedd, PA. In this role, he supports the Medical Device and Combination Product (MDCP) and digital health solutions business across Merck. George provides guidance and support for more than 40 products, including auto injectors, prefilled syringes, digital health software, and contraceptives.

George has extensive experience with the Product Development Lifecycle, including product safety, regulatory submissions, quality assurance, and clinical affairs. Prior to joining Merck, he worked at Sanofi in Swiftwater, PA, as a Pharmacovigilance Scientist for postmarket and clinical vaccine and drug products, and as a Research Associate focused on clinical pharmaceutical and vaccine applications and discovery. George also has extensive experience as a research scientist, managing research and clinical teams at Johns Hopkins University and SUNY Upstate Medical University.

George received an M.S. in Regulatory Affairs / Quality Assurance from Temple University in Philadelphia, an M.S. in Bioengineering from Syracuse University in New York, and a B.S. in Biology from Wilkes University in Wilkes Barre, PA. He is a member of RAPS to which he holds the RAC certification, ASQ, and DIA professional societies and holds ISO certifications in Quality Management Systems Requirements (ISO 9001), Information Security Management (ISO 27001), Service Management Systems (ISO 20000), and Medical Devices Quality Management Systems (ISO 13485). He is also an author of 14 peer-reviewed publications.