Dhriti Roy

VP of Regulatory Affairs Transformation at Essenvia

Speaker

Dr. Dhriti Roy is the Vice President of Regulatory Affairs Transformation at Essenvia, who has over 20 years of experience as a regulatory affairs executive and digital transformation expert across various industries such as medical devices, in vitro diagnostics, pharmaceuticals, biologics, and consumer products. Dr. Roy has demonstrated successful leadership and expertise in the execution of quality, regulatory, and clinical strategies for market-leading companies like Abbott, Medtronic, Zoll, Danahar, and Labcorp, as well as early-stage organizations.

She assists manufacturers in submitting IDEs, PMA, and 510 (K) for Class I to Class III devices. Dr. Roy specializes in FDA regulatory compliance, EU MDR and IVDR transition, SaMD and SiMD device regulations in cardiovascular, radiology, critical care, organ perfusion systems, and more. Notably, she has led worldwide regulatory efforts on the buy and sell side for M&A deals ranging from $100 million to more than $5 billion in individual value.

Dr. Roy holds a doctorate in environmental engineering and an MBA from the University of Oxford. She is also a leading scientist and has contributed to highly-ranked scientific research publications. As a faculty at Oxford University, she mentors Innovations and market access in the medical technologies sector. Additionally, she serves as a board member and investor for a venture capital firm focused on impact investment funds for early-stage ventures in the health technology sector.