Hamed Rahimi
Regulatory Affairs Lead | US, EU, and International | Regulatory Strategy, Compliance, and Product Lifecycle Management | AdPromo and Labeling Review | Advancing Safe and Innovative Medical Technologies
- Role
- Regulatory Affairs at Smith Nephew
- Location
- Chesapeake, VA, US
- LinkedIn followers
- 500 followers
About Hamed Rahimi
Regulatory Affairs professional with a strong track record leading U.S. and international submissions for Class II & Medical Devices and Combination Drug-Device products, including 510(k)s, PMAs, and EU MDR Technical Files. I bring a unique blend of regulatory strategy, global registration expertise, and hands-on NPD/R&D experience, enabling effective cross-functional collaboration and the execution of timely, compliant pathways that support successful product development and commercializationSkills and Expertise:• Expertise in Quality Management Systems (GMP, 21 CFR 820, ISO 13485, 21 CFR 210–211) and Risk Management (ISO 14971)• Authored and led U.S. and EU regulatory submissions, and served as Franchise Lead for international registrations across APAC and LATAM• Developing regulatory strategies for product development, market growth, and process improvement.• Advertising & promotional material review• PMP and RAC Certified.
Experience
Regulatory Affairs
Apr 2022 — Present
Education
Saint Louis University
Doctor of Philosophy (Ph.D.), Biomedical Engineering
Oklahoma State University
Master of Science (MS), Mechanical Engineering
Amirkabir University of Technology - Tehran Polytechnic
Bachelor of Science (BS), Biomedical Engineering
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