Samuel has over a decade of experience and expertise in biomedical research and the regulatory/clinical space with an extensive background in developing and implementing path-to-market strategies, regulatory submissions, and clinical programs for a wide array of therapeutic technologies in the US, EU, and Japan.  

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As General Manager of Vorpal Technologies, Sam is passionate about helping companies navigate the complexities of the Japanese regulatory, clinical, reimbursement, and commercialization landscape.
 

Previously, Sam served as Director of Regulatory Affairs at MCRA, where he focused on the development of regulatory submissions, design and implementation of clinical trials, and assessment of pre-clinical and clinical data in a wide array of therapeutic areas including orthopedics, cardiovascular, and wound care. 

Since joining MCRA in 2013, Sam has developed and reviewed hundreds of regulatory submissions for medical devices including 510(k)s, PMAs, De Novos, and IDEs.  In addition, he has developed and reviewed submissions for CDER and CBER products, as well as combination products including IND and pre-IND submissions. He also has many years of international regulatory experience, authoring and reviewing numerous CERs and Technical Files, and assisting with PMDA submissions.

Prior to joining MCRA, Sam worked as a research associate in tissue engineering at the Medical University of South Carolina in Charleston, SC and Clemson University, conducting research in bioprinting and stem cell technology. Sam received his Bachelor of Science in Bioengineering at Clemson University. He is RAC-certified and is an active member of the Regulatory Affairs Professional Society.