Jit Magar
Sr. Regulatory Affairs Specialist at Johnson & Johnson
- Role
- Senior Regulatory Affairs Specialist at Johnson & Johnson
- Location
- Cincinnati, OH, US
- LinkedIn followers
- 500 followers
About Jit Magar
Experienced Sr. Regulatory Affairs Specialist (Medical Device), have a proven track…
Experience
Senior Regulatory Affairs Specialist
Apr 2025 — Present · Cincinnati, OH, US
Prepare, compile, and submit regulatory documents.(FDA-510(k), CE-Technical Files, PMA, EU-MDR submissions).• Ensure all documentation complies with global regulatory requirements (FDA, EU MDR, Health Canada, TGA, etc.).• Develop and execute regulatory strategies for new products, changes to existing products, and global market entry.• Provide regulatory input during product development and design changes.• Ensure products comply with relevant standards (e.g, ISO 13485, ISO 14971).• Monitor regulatory changes and advise the organization on impact and compliance.• Work closely with R&D, Quality, Clinical, and Marketing teams to align regulatory requirements with business objectives.• Participate in design control and risk management activities.• Review product labels, instructions for use (IFUs), and promotional materials to ensure regulatory compliance.• Support internal audits and regulatory inspections (e.g, FDA, Notified Bodies), Assist with audit responses and CAPAs related to regulatory findings.
Education
Tribhuvan University
Associate's degree
2007 — 2009
Université de Franche-Comté
Master of Engineering - MEng
2016 — 2018
Tribhuvan University
Bachelor of Science - BS
2010 — 2013
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