Job Title:
RA & QA Engineer – Regulatory & Safety (Radiology & Imaging Systems)
Department:
Regulatory & Safety – Radiology Division
Location:
Vapi, Gujarat
Reports To:
Manager / Senior Manager.
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.
- Coordin...