Sr. Executive- Regulatory Affairs (RA)

Auxein Medical Pvt. Ltd.; Kundli; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Auxein Medical Pvt. Ltd. seeks a Regulatory Strategy & Compliance specialist to manage regulatory submissions and ensure ongoing compliance for medical devices across US and EU markets.

You will coordinate regulatory activities, drive documentation, and support UDI submissions. The ideal candidate has 4+ years in regulatory affairs for medical devices, with knowledge of FDA, EU MDR, and CDSCO regulations, and RAC/GATE is a plus.

Qualifications

• BE/BTech in Mechanical, Biomedical, Biotech, or related fields.
• Minimum 4 years of experience in Regulatory Affairs for medical devices.
• Knowledge of U.S. FDA, EU MDR, CDSCO regulations.
• RAC/GATE certification is a plus.

Responsibilities

• Prepare regulatory submissions and documentation for US FDA, EU MDR, and CDSCO.
• Regulatory monitoring, reporting, and lifecycle management for medical devices.
• Coordinate UDI submissions to GUDID and EUDAMED databases.
• Support regulatory audits, inspections, CAPAs, and NC closures.

Skills

Regulatory Affairs

FDA Regulations

EU MDR

CDSCO Regulations

Documentation & Submissions

Education

BE/BTech in Mechanical, Biomedical, Biotech, or related fields

Tools

Regulatory Submissions Software

Job description

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