Sr. Executive- Regulatory Affairs (RA) (Sonipat)

Sr. Executive- Regulatory Affairs (RA) (Sonipat)

22 Oct
|
Auxein Medical
|
Sonipat

22 Oct

Auxein Medical

Sonipat

Job description

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 4 years of exp. in RA for medical devices
Knowledge of U.S. FDA, EU MDR, CDSCO regulations
RAC/GATE certification is a plus

📌 Sr. Executive- Regulatory Affairs (RA) (Sonipat)
🏢 Auxein Medical
📍 Sonipat

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