Sabyasachi is responsible for strategic and operational leadership of regulatory and quality initiatives to grow Welldoc’s digital healthcare products. Sabyasachi brings a strong track record in engineering, life sciences, premarket / post-market medical device regulatory as well as quality system activities in support of commercial and clinical investigational use devices. Sabyasachi has extensive experience in new product development, regulatory authorizations and post-market compliance of medical devices that utilize artificial intelligence, advanced signal processing algorithms implemented on mobile platforms.
Prior to joining Welldoc, Sabyasachi served as the Senior Director of Regulatory Affairs, Quality Assurance and Compliance at BrainScope®. Sabyasachi played a pivotal role in introducing BrainScope’s novel mobile medical devices for brain injury assessment that are in distribution in hospital emergency departments, urgent care centers, and military healthcare facilities.
Sabyasachi earned his Ph.D. in biomedical engineering from the Johns Hopkins University School of Medicine (Baltimore) and holds a Master of Science degree from Montana State University (Bozeman). Sabyasachi is a member of the Regulatory Affairs Professional Society (RAPS), has published several journal articles and serves as a medical device journal reviewer.