Rachit Parikh
Regulatory Affairs Director
- Role
- Director of Regulatory Affairs at Reprieve Cardiovascular
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Rachit Parikh
Seasoned Regulatory Affairs Professional with extensive expertise in navigating US FDA, EU MDR, and global regulatory frameworks. Proven track record of securing approvals for high-risk (Class medical devices, including Original PMA, PMA-S, 510k, Pre-Subs, CE Mark, and a wide range of post-market submissions.Experienced in crafting robust regulatory strategies, leading interactions with regulatory agencies, and developing streamlined processes to ensure consistent and successful outcomes. A collaborative team player who thrives in cross-functional environments, adept at negotiating deliverables, and driving high-quality submissions.Recognized for outstanding leadership, exceptional communication, and compelling presentation skills, I am committed to supporting innovation while ensuring compliance in the evolving medical device landscape
Experience
Director of Regulatory Affairs
Oct 2025 — Present · Milford, MA, US
Education
University of Mumbai
Bachelors, Biomedical Engineering
2003 — 2007
The University of Toledo
Master’s Degree, Bioengineering
2007 — 2010
UC Irvine
Medical Device Product Development Certification Program
2011 — 2012
Skills
- Quality System
- Quality Systems
- Statistics
- Medical Imaging
- Engineering
- Finite Element Analysis
- Regulatory Affairs
- Orthopedic
- Astm
- Biomaterials
- Mechanical Testing
- Spine
- Testing
- Product Development
- Biomechanics
- Cad
- Medical Devices
- Iso
- Orthopedics
- Fda
- Biomedical Engineering
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