Sam serves as the General Manager of MCRA Japan (a.k.a. Vorpal Technologies), where he assists companies in navigating Japan market entry through the PMDA and MHLW processes. As part of this role, Sam and his team provide consulting services in regulatory, reimbursement, clinical, and commercialization (including D-MAH) activities.
Sam has over 10 years 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. As General Manager of Vorpal Technologies, Sam is passionate about helping companies navigate the complexities of the Japanese regulatory, clinical, reimbursement, and commercialization landscape.
Sam received his Bachelor of Science in Bioengineering at Clemson University and holds a Regulatory Affairs Certification (RAC).
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 2014, Sam has developed and received 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, authorizing 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. As part of this work, he has published several peer reviewed papers in this field.
Overview
Mr. Pollard is a passionate, highly accomplished regulatory and clinical advisor. At MCRA, he has led a multitude of successful regulatory approvals and clinical studies across the US, EU, and Japan in spine, orthopedics, cardiovascular, wound care, and general surgery.