Manthan Damani

About Manthan Damani

A creative & focused mind, a values-oriented & optimistic demeanor coupled with dedication, hard work and efficient team player skills. With a graduate degree in Regulatory Affairs, solid hands-on experience as well as a biomedical engineering background, I am interested in pursuing unique challenges and finding practical solutions to problems with the core motive of ensuring development of quality medical products that are safe and effective for billions of patients around the world.Specialties: Quality System Regulations, 21 CFR 820, ISO 13485, Quality Control practicesUS Class I, Class II, and EU Class I, Class IIa, Class IIb medical devicesKnowledge of IDE, 510(k), PMA, HDE, De Novo submissions for medical devicesSTED files, and EU Tech filesRisk Analysis, V&V testing, performance testing, ISO 10993- Biological Evaluation of medical devices, IEC 60601 testingKnowledge of IND, NDA, Orphan drug designations, Fast Track filings for new drugsBiologic submissions including IND and BLASafety and Annual ReportsProduct Labeling, Advertising and PromotionInternational guidelines of ICH, GHTF, IMDRFClinical trials, Food and Drug LawRegulatory Affairs Strategic Planning and Project Management

Experience

1. Senior Manager, Regulatory Affairs

   BD

   Jul 2025 — Present · Irvine, CA, US

Education

• University of Mumbai

  B.E., Biomedical Engineering

  2005 — 2009

• Northeastern University

  MS, Regulatory Affairs for Medical Devices, Drugs and Biologics

  2011 — 2013

Skills

• Labview
• Fast Learner
• Medical Devices
• Capa
• Quality System
• V&V
• Team Player
• Strategy
• Biomedical Engineering
• Regulatory Affairs
• Punctual
• C++
• Regulatory Filings
• R&D
• Regulatory Strategy
• Iso 13485
• Quality Control
• Regulatory Reporting
• Fda
• Microsoft Office
• Regulatory Requirements
• Quick Learner
• Regulatory Submissions
• Able to Multi-Task
• C