23 Oct
|
Auxein Medical
|
Sonipat
23 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