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