Shibir Desai
Director, Regulatory Affairs (Chapter Lead), Roche Information Solutions @Roche
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WORK HISTORY
Director, Regulatory Affairs (Chapter Lead), Roche Information Solutions @Roche
Lead, develop, and grow domestic and international regulatory team based on business needs -Presubmission, De Novo, and 513(g) for stand-alone software and SaMD -Member of Roche’s team for the FDA Software Pre-Certification Pilot Program -Leading regulatory team strategies for digital health based on 21st Century Cures Act, AI/ML, and other FDA/international guidances -EU MDR and IVDR Compliance
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
Director, Regulatory Affairs (Chapter Lead), Roche Information Solutions at Roche
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