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 certificates are updated and aligned with current regulatory norms. Coordinate the submission and follow-up of applicatio...