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Dr. Darin S. Oppenheimer is an Executive Director of the Drug Device Center of Excellence focusing on Medical Devices and Combination products at Merck based in Upper Gwynedd, PA. Darin is involved in many facets of the Product Development Lifecycle including regulatory submissions, due diligence, and active participation on industry trade organizations and standards committees over the past 15 years. His prior background as a Research and Development Scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery. Darin’s undergraduate degree is in Molecular Biology from the University of Tampa. He also holds two Masters Degrees from Johns Hopkins University in Biotechnology and Regulatory Science as well as a graduate Certificate in Biotechnology Enterprise. Recently Darin has completed his Doctorate degree in Regulatory Science from the university of Southern California. Darin is also a 2017 Regulatory Affairs Professional Society Fellow.