Sabyasachi Roy
Head of Regulatory Affairs - Enterprise Informatics, Innovation & Strategy @ Philips | Biomedical Engineering
- Role
- Head of Regulatory Affairs - Enterprise Informatics, Innovation & Strategy at Philips
- Location
- Columbia, MD, US
- LinkedIn followers
- 500 followers
About Sabyasachi Roy
Experienced in medical device product development lifecycle from concept to design and development, launch and postmarket surveillance. Specialized in pre-market and post-market regulatory activities of medical devices using sophisticated sensor technologies, signal processing and software. Strong track record in developing and bringing to market artificial intelligence (AI), machine learning (ML) based medical devices that dominate head injury and concussion assessment. Experienced as Management Representative and responsibility of maintaining medical device design and development processes, quality assurance standards (ISO 13485, MDSAP). Managed relationship with regulatory entities such as FDA, Health Canada, notified bodies such as TUV, BSI, Intertek, and CRO such as Parexel. Excellent interpersonal skills to work effectively with internal team members as well as external partners and vendors. Strong combination of strategic thinking and day-to-day problem solving, acting decisively and ability to provide both strategic and operational guidance.
Experience
Head of Regulatory Affairs - Enterprise Informatics, Innovation & Strategy
Jun 2023 — Present · Washington, DC, US
Education
B. M. S. College of Engineering
Bachelor of Engineering (BE), Electrical, Electronics and Communications Engineering
1997 — 2001
The Johns Hopkins University
PhD, Biomedical Engineering
2005 — 2012
Montana State University-Bozeman
Master of Science (MS), Electrical Engineering
2002 — 2004
Kendriya Vidyalaya
High School
1985 — 1997
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