- Ph.D., Materials Science and Engineering, University of Pennsylvania, 2006
- M.S., Materials Science and Engineering, University of Pennsylvania, 2004
- B.S., Physics, Saint Joseph's University, 2001
- B.S., Chemistry, Saint Joseph's University, 2000
- Member of Sigma Xi - Scientific Research Honor Society
- Member of Sigma Pi Sigma – University Physics Honor Society
Dr. Nicholas Benetatos joined Exponent in 2019 bringing a wealth of knowledge and experience in regulatory affairs related to medical devices, combination products, pharmaceuticals and their associated underlying science. He advises clients on the strategic planning and the execution of important regulatory activities throughout the total product lifecycle including those impacting design and development, regulatory submissions, and post-market compliance.
Prior to joining Exponent, Nicholas held tactical and strategic regulatory affairs roles of key responsibility for large (Fortune 100) global business segments in the medical device and pharmaceutical sectors. In addition, Nicholas spent 7 years with the US-FDA Center for Devices and Radiological Health focused on regulatory science, regulatory review, and science-based decision making for total product lifecycle and public health issues. His experience has crossed a diverse range of disease states and technologies including: cardiovascular and interventional cardiology, orthopedics, ophthalmics, diabetes, drug-delivery systems, biodegradable implants, digital health solutions, wearables, pediatric devices, and active implantable electronic devices.
Nicholas is well versed in preparing regulatory submissions and providing stakeholders/customers with strategic direction and understanding of global regulatory landscapes, requirements, and risks. He has provided expert testimony and represented large organizations to health authorities - leading interactions, negotiations, and alignment regarding pathways for new product development, clinical, lifecycle management, and responses to review inquiries/deficiencies/audit findings etc. Device experience has included IDE, PMA, PMA supplements, 510k, CE marking, as well as early phase (IND, IMPD), registration (NDA, MAA), and post market support (sNDA) for drug-device combination products.
Nicholas received a PhD in Materials Science and Engineering from the University of Pennsylvania and has led multidisciplinary laboratory research in polymer science and regulatory science to further the understanding of the fundamental scientific issues that underlie regulatory decisions for new/emerging biomedical technologies. Laboratory work has investigated, for example, the complex inter-relationships between materials structure, manufacturing/processing methods, real-world performance, product safety/efficacy, and failure modes in materials, biomedical devices, and complex combination products.