Shibir Desai
Head of Regulatory Affairs, Roche Information Solutions @Roche
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WORK HISTORY
Head of Regulatory Affairs, Roche Information Solutions @Roche
Lead and scale high-performing domestic and international regulatory affairs teams aligned with evolving business needs-Expanded regulatory team from 1 to ~20 employees, increasing support from 5 products to nearly 100, across diverse digital platforms-Drive global regulatory strategy and submissions for stand-alone software, including Pre-Submissions, 510(k), De Novo, technical documentation, 513(g) pathways, alignment with notified body, etc-Provide regulatory leadership in digital health, with deep expertise in the 21st Century Cures Act, EU AI Act, Clinical Decision Support, cybersecurity, and other FDA and global guidance frameworks-Strategically navigate, assess, qualify, and classify software products, including Software as a Medical Device (SaMD), AI/ML applications, software supporting diagnostics, wearable-integrated tools, imaging software, and clinical trial platforms-Ensure robust EU MDR and IVDR compliance across software and diagnostic product portfolios
EDUCATION
Santa Clara University Law School
J.D.
University of Southern California
B.S., Biomedical Engineering
Harker High School
H.S. Diploma
University of Southern California
M.S., Biomedical Engineering
ABOUT SHIBIR DESAI
Head of Regulatory Affairs, Roche Information Solutions at Roche
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