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Executive/ Sr. Executive- Regulatory Affairs (RA)

Executive/ Sr. Executive- Regulatory Affairs (RA)

Auxein Medical

2 years

0 Lacs

Sonipat Haryana India

Posted:2 months ago| Platform:

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Skills Required

strategy compliance mdr documentation monitoring reporting audits regulations certification

Work Mode

On-site

Job Type

Full Time

Job Description

Responsibilities Regulatory Strategy & Compliance – US FDA, EU MDR, CDSCO Documentation & Regulatory Submissions Regulatory Monitoring & Reporting UDI Submission – GUDID / EUDAMED Regulatory Audits, Inspections, CAPAs & NCs Closure Qualifications 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 Show more Show less

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Auxein Medical

Medical Equipment Manufacturing

Sonepat Haryana

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Executive/ Sr. Executive- Regulatory Affairs (RA)