Regulatory Affairs Specialist - Radiology

Job Title :

Regulatory Affairs Executive – Regulatory & Safety (Radiology & Imaging Systems)

Department :

Regulatory & Safety – Radiology Division

Location : Vapi, Gujarat

Reports To :

Manager / Senior Manager – Regulatory & Safety

Job Purpose :

To manage and coordinate regulatory documentation and compliance activities for radiology and imaging systems such as X-Ray, C-Arm, Digital Radiography (DR), and CT equipment , ensuring adherence to BIS, AERB, NABL , and international regulatory standards applicable to medical device manufacturing.

Key Responsibilities :

1. Regulatory Documentation and Compliance

• Prepare, review, and maintain documentation for product approvals and certifications from BIS (Bureau of Indian Standards), AERB (Atomic Energy Regulatory Board), and NABL (National Accreditation Board for Testing and Calibration Laboratories).
• Ensure all technical files, QA test reports, and compliance certificates are updated and aligned with current regulatory norms.
• Coordinate the submission and follow-up of applications for new product registrations, renewals, and amendments.
• Track changes in regulatory requirements and ensure timely updates to internal documentation and procedures.

2. Product and Process Compliance

3. Coordination with Regulatory Authorities

4. Documentation Control and Audits

5. Cross-Functional Support

Qualifications and Experience :

Skills and Competencies :

Key Performance Indicators (KPIs) :