Gaurab Dutta
Frederick,USA
Summary
Regulatory Policy Analyst & Lead Reviewer with extensive experience in FDA regulations and compliance. Demonstrated expertise in optimizing regulatory pathways for medical devices, resulting in enhanced support for medical innovation and improved patient safety. Proven ability to lead cross-functional teams and effectively engage stakeholders, ensuring alignment with regulatory standards. Career aspirations include further advancing regulatory strategies that facilitate safe and effective healthcare solutions.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Regulatory Policy Analyst/Lead Reviewer
US Food and Drug Administration (FDA)
Silver Spring, USA
08.2022 - Current
- Led the development of regulations and policies impacting Breakthrough Devices, Safer Technologies (STeP), and Investigational Device Exemption (IDE) programs, ensuring streamlined pathways for innovative medical devices.
- Provided strategic support for policies and programs related to clinical evidence generation, optimizing regulatory pathways for breakthrough, and safer technologies.
- Led reviews of regulatory submissions for sleep disorder and respiratory monitoring devices to validate adherence to FDA standards.
- Enhanced post-market surveillance strategies by addressing identified product risks.
Postdoctoral Researcher
University of California, Los Angeles
Los Angeles, CA
10.2021 - 08.2022
- Developed implantable, wirelessly powered biosensing devices for point-of-care diagnostics in mobile health applications.
- Applied surface electrochemistry-based analytical techniques for biosensor optimization.
- Applied surface electrochemistry-based analytical techniques for biosensor optimization.
- Mentored graduate students and researchers, and assisted in preparing proposals for externally funded grants and patents, securing over $2 million in funding.
- Led research team meetings, facilitating discussion and collaboration among members.
- Reviewed journal articles for publication in scientific journals.
Research Associate (Visiting Scholar)
Louisiana Tech University
Ruston, USA
06.2020 - 09.2021
- Examined corrosion and fracture characteristics of 3D-printed stainless steel in biofluids and saline environments.
- Developed a perovskite-based gas sensor for vehicle and space applications, enhancing sensor technology, and expanding its application scope.
- Presented research findings at national and international conferences.
Postdoctoral Research Associate
University Of New Hampshire
Durham, NH
02.2018 - 05.2020
- Developed single-chain templated polymer-based electrochemical sensors for neurochemical detection.
- Supported acquisition of $500,000 grant by developing groundbreaking methodology for simultaneous monitoring of key biological molecules.
- Engineered process for isolating TMD nanosheets using liquid-phase exfoliation, ensuring precision and consistency.
Education
Ph.D. - Engineering
Louisiana Tech University
Ruston, LA08.2017
M.S. - Electrical Engineering
Louisiana Tech University
Ruston, LA05.2017
M.Tech. - Control & Instrumentation
West Bengal University of Technology
India07.2008
B.Tech. - Electrical Engineering
West Bengal University of Technology
India07.2006
Skills
- Analytical and scientific writing
- Regulatory compliance
- Understanding FDA regulations
- Policy interpretation
- Excellent communication
- Risk assessment of medical devices
- Team management
- Stakeholder engagement
- Team collaboration
Regulatory And Compliance Expertise
- Medical Device Submissions: 510(k), PMA, IDE, De Novo, Q-Submissions, PAS and Subject matter Expert on Electrical Safety, EMC, MR Compatibility
- Risk Management & Post-Market Surveillance: MDR Analysis, Signal Detection
- Regulatory Compliance: FDA, ASTM (F2052, F2119, F2182, F2213, F2503), ISO (10993, 14708), IEC Standards (60601)
- Cross-functional Collaboration: Engaging with internal teams, industry partners, and regulatory agencies
Affiliations
- E· Reviewer Board Member, MDPI, 01/2021, Present
- Nominated Associate Member, Sigma Xi Scientific Research Honor Society, 01/2020, Present
- Peer Reviewer for Journals
- · Elsevier
- · MDPI
- · Hindawi
- · Reviewed 50+ research articles
- · Six-Sigma Green Belt Certification in Quality Control and Statistical Analysis, 01/2016, Present
- · Technical Committee Member, IEEE Conference on Applied Signal Processing (ASPCON), 01/2018, Present
Certification
• Six-Sigma Green Belt Certification
• Working Knowledge of ISO 9001, ISO 13485:2003, and ISO 14971:2007
• Good Documentation Practices (GDP) & cGMP Compliance Training
Publications
- Author of multiple peer-reviewed journal articles on medical device materials, corrosion science, and electrochemical sensors (Google Scholar Link).
- Speaker at Electrochemical Society (ECS) Meetings, IEEE Conferences, and NIH-sponsored event.
- https://publons.com/researcher/1665591/gaurab-dutta (Research Profile)
References
References available upon request.
Timeline
Regulatory Policy Analyst/Lead Reviewer
US Food and Drug Administration (FDA)
08.2022 - Current
Postdoctoral Researcher
University of California, Los Angeles
10.2021 - 08.2022
Research Associate (Visiting Scholar)
Louisiana Tech University
06.2020 - 09.2021
Postdoctoral Research Associate
University Of New Hampshire
02.2018 - 05.2020
Ph.D. - Engineering
Louisiana Tech University
M.S. - Electrical Engineering
Louisiana Tech University
M.Tech. - Control & Instrumentation
West Bengal University of Technology
B.Tech. - Electrical Engineering
West Bengal University of Technology
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