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Executive/ Sr. Executive- Regulatory Affairs (RA) Auxein Medical

2.0 - 7.0 years

3 - 8 Lacs

Sonipat

Work from Office

Regulatory Strategy & Compliance – US FDA, EU MDR, CDSCO Documentation & Regulatory Submissions Regulatory Monitoring & Reporting UDI Submission – GUDID / EUDAMED Regulatory Audits, Inspections, CAPAs & NCs Closure Required Candidate profile BE/BTech in Mechanical, Biomedical, Biotech, or related fields Min 2 years of exp. in RA for medical devices Knowledge of U.S. FDA, EU MDR, CDSCO regulations RAC/GATE certification is a plus

Posted 3 weeks ago

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Sr. Executive/ Assistant Manager- Regulatory Affairs (RA) Auxein Medical

3 - 8 years

4 - 9 Lacs

Sonipat/Sonepat

Work from Office

Regulatory Strategy & Compliance US, FDA, MDR Documentation & Submissions Regulatory Monitoring/ Reporting, Submission of UDI to GUDID/EUDAMED Regulatory Audits and Inspections CAPAs, NCs closure Navigating regulatory requirement for CDSCO, US FDA Required Candidate profile BE/BTech- Mech. min. 3+ years of exp. in regulatory affairs with medical device industry, strong understanding of U.S. FDA and European regulatory requirements, EU MDR 2017, ISO 13485, RAC, CDSCO.

Posted 3 months ago

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