Gaurab Dutta
General Engineer @FDA
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WORK HISTORY
General Engineer @FDA
Washington, DC, US
Provided policy and program support for clinical evidence-related programs, including Breakthrough, Safer Technologies Program (STeP), IDE, and Expanded Access of Medical Devices.• Drafted and critically reviewed documents related to policy proposals, regulations, guidance, proposed legislation, and policy statements.• Led the review of market submissions for sleep disorder and respiratory monitoring devices, ensuring a favorable benefit-risk profile for US market approval.
EDUCATION
Maulana Abul Kalam Azad University of Technology, West Bengal formerly WBUT
Bachelor of Technology (B.Tech.), Electrical Engineering
West Bengal State Council for Technical education
Diploma in electrical engineering, Electrical Enigneering
Louisiana Tech University
Doctor of Philosophy (Ph.D.), Micro and Nanosystem Engineering
Louisiana Tech University
Master's in science, Electrical engineering
SKILLS
ABOUT GAURAB DUTTA
Passionate about the intersection of materials science, biomedical engineering, and regulatory strategy, I specialize in advancing next-generation medical technologies. With a strong background in electrochemical sensing, AI-driven diagnostics, and wearable biosensors, I am committed to bridging the gap between innovative research and real-world healthcare solutions.Currently, I serve as a General Engineer at the FDA, contributing to the Breakthrough Designation and Safer Technologies Program (STEP), and other clinical evidence-related programs. My role involves evaluating and supporting cutting-edge medical devices, ensuring they meet the highest standards for safety and effectiveness.My expertise spans EIS-based biosensing, AI-integrated medical devices, and regulatory science, with a focus on enabling transformative healthcare innovations. I am particularly interested in how machine learning, advanced materials, and sensor technology can revolutionize patient care.Always open to collaborations, discussions, and innovations in the fields of biomedical technology, AI-driven healthcare, and regulatory pathways for emerging medical devices.
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