Biography
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. 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.
Professional Experience
Regulatory Affairs Professional with more than 14 years of experience in scientific research and regulatory affairs management with strong skills and various leadership roles in the medical device and pharmaceutical industries
- In depth knowledge of global medical product regulations for the United States, Canada, Europe, Middle East, Asia, and Latin America countries
- Broad understanding of global medical product licensure applications, 21 CR 820, 21 CFR Part 4, USP Monographs, Medical Device Directives (MDD), In Vitro Diagnostic Directive (IVDD), Human Factors, ISO 13485, ISO 14971, IEC 60601, IEC 62304, 510(k), PMA, Combination Products IND, CTA, NDA, IDE, BLA, Unique Device Identifier (UDI), and Companion
- Solid business management acumen involved in strategic planning, geographic product expansion, resource allocation, cross-functional team building and demonstrated leadership capabilities
- Exceptional written and verbal communication skills to effectively convey complex information to audiences from diverse backgrounds and at various organizational levels
- Strong experience in hands-on scientific research and development with expertise in companion diagnostic biomarker development
- Frequent subject matter expert speaker within the Regulatory Professional Societies, and Academia presenting current trends in regulatory sciences and non-compliance issues
Professional Activities & Accomplishments
- Green Belt, Six Sigma Process Excellence
- 1 patent
- 9 publications
- 39 symposiums
