Regulatory & QA Engineer - Radiology

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 certifi...