Radiation Safety Executive

Job Title: Radiation Safety Executive – Regulatory & Safety (Radiology & Imaging Systems) Department: Regulatory & Safety – Radiology Division Location: Vapi, Gujarat Reports To: Manager / Senior Manager – Regulatory & Safety Job Purpose: To ensure radiation safety, regulatory compliance, and statutory licensing for radiology and imaging systems such as X-Ray, C-Arm, Digital Radiography (DR), and CT Scan equipment , in alignment with AERB (Atomic Energy Regulatory Board) and NABL (National Accreditation Board for Testing and Calibration Laboratories) guidelines. Key Responsibilities: 1. Radiation Safety Management Implement and monitor radiation safety protocols across all radiology equipment manufacturing, testing, and validation areas. Conduct radiation surveys, leakage testing, and shielding verification to ensure workplace and personnel safety. Maintain records of radiation exposure and ensure that all activities are performed within prescribed AERB safety limits. Ensure availability, calibration, and proper usage of radiation monitoring devices and personal dosimeters. 2. Regulatory Compliance and Licensing Handle and coordinate AERB licensing for manufacturing, installation, and servicing of X-Ray, C-Arm, DR, and CT systems. Prepare, maintain, and submit documentation required for AERB, NABL, and ISO 13485 compliance. Liaise with regulatory authorities for approvals, renewals, audits, and inspections. Ensure all testing facilities and radiation-emitting devices are in compliance with AERB and BIS 13450 standards. 3. Radiation Safety Officer (RSO) Duties Act as the designated Radiation Safety Officer (RSO) for the radiology production facility. Provide training and guidance to employees on radiation safety practices and emergency preparedness. Investigate and report any incidents involving radiation exposure or non-compliance. Review safety measures periodically and recommend improvements to enhance radiation protection. 4. Quality and Documentation Maintain detailed and up-to-date records of radiation monitoring, calibration, and licensing documentation. Support internal and external audits related to radiation safety and regulatory compliance. Collaborate with Quality, Production, and R&D teams to ensure radiation safety is integrated into product design and process workflows. 5. Cross-Functional Coordination Work closely with Testing, QC, and Maintenance teams to ensure radiation-emitting components are handled safely and within regulatory guidelines. Coordinate with facility management for implementation of shielding, warning signage, and access control systems in radiation areas. Support customer site regulatory documentation for installation and commissioning of imaging systems. Qualifications and Experience: B.E. / B.Tech/Diploma in Electronics or Biomedical Engineering . AERB-certified Radiation Safety Officer (RSO) is mandatory 3–5 years (or more) of experience in QA Test , radiation safety, compliance, or regulatory management within a radiology or medical imaging equipment manufacturing environment. Sound knowledge of AERB, NABL, ISO 13485, and BIS 13450 standards. Hands-on experience with X-Ray, C-Arm, DR, and CT assemblies and testing setups preferred. Skills and Competencies: Strong understanding of radiation physics, protection principles, and safety standards. Excellent knowledge of AERB regulatory processes and documentation. Attention to detail with strong analytical and problem-solving abilities. Good communication and coordination skills for interfacing with internal teams and regulatory bodies. Proficiency in MS Office, ERP, and documentation systems. High sense of responsibility, discipline, and integrity in maintaining safety compliance. Key Performance Indicators (KPIs): 100% compliance with AERB licensing and radiation safety regulations Timely submission and renewal of regulatory licenses Zero safety incidents or non-compliances Accuracy and completeness of radiation safety documentation Successful completion of internal and external audits