Job Title:
Radiation Safety Officer – Regulatory & Compliance.
Department:
Radiation Safety & Product Compliance.
Location:
Vapi, Gujarat
Reports To:
Manager / Senior Manager – Radiology
Job Purpose:
To ensure radiation safety, regulatory compliance, BIS certification, and statutory licensing activities for medical imaging systems including X-Ray, Mobile X-Ray, Digital Radiography (DR), C-Arm, Mammography, Fluoroscopy, and CT systems. The role is responsible for implementing radiation protection programs, managing AERB approvals, supporting BIS certification activities, and ensuring compliance with applicable national and international standards throughout the product lifecycle.
Key Responsibilities:
Radiation Safety Management
• Implement and monitor radiation safety programs across R&D, manufacturing, testing, validation, and service operations.
• Conduct radiation leakage measurements, area surveys, shielding assessments, and workplace radiation monitoring.
• Ensure occupational radiation exposure remains within prescribed AERB limits.
• Maintain personnel dosimetry records and radiation monitoring documentation.
• Ensure availability, calibration, and proper utilization of radiation survey meters, dosimeters, and monitoring instruments.
• Support radiation risk assessments and implementation of corrective actions for identified safety concerns.
Regulatory Compliance & AERB Licensing
• Coordinate AERB approvals, registrations, licensing, amendments, and renewals for radiation-emitting medical devices.
• Manage documentation and submissions through AERB regulatory systems.
• Ensure compliance with Atomic Energy Act, Radiation Protection Rules, and applicable AERB Safety Codes.
• Liaise with AERB officials during inspections, audits, and regulatory reviews.
• Maintain regulatory records and ensure timely closure of observations arising from audits and inspections.
BIS Certification & Standards Compliance
• Support BIS certification activities for medical imaging equipment.
• Coordinate testing and certification activities with BIS-recognized and NABL-accredited laboratories.
• Prepare compliance documentation, technical files, test reports, and certification dossiers.
• Ensure product compliance with applicable standards including:
• BIS / IS 13450
• IEC 60601 Series
• ISO 13485
• ISO 14971
• Other applicable medical device standards
• Track changes in regulatory and certification requirements and support implementation within the organization.
Product Safety & Quality Support
• Support product verification and validation activities related to radiation performance and safety.
• Participate in design reviews and provide radiation safety inputs during product development.
• Collaborate with R&D teams to ensure compliance requirements are incorporated into product design.
• Assist in risk management and hazard analysis activities related to radiation-emitting devices.
• Support CAPA, change control, and product improvement initiatives.
Documentation & Audit Support
• Maintain accurate records related to radiation monitoring, licensing, certifications, calibration, and compliance activities.
• Support internal, external, BIS, ISO 13485, and AERB audits.
• Prepare audit documentation, compliance reports, and management review inputs.
• Ensure traceability and document control as per quality management system requirements.
Cross-Functional Collaboration
• Work closely with R&D, Quality Assurance, Manufacturing, Testing, Service, and Regulatory Affairs teams.
• Coordinate with facility management regarding radiation-controlled areas, shielding requirements, warning systems, and access controls.
• Support installation and commissioning teams with regulatory and radiation safety documentation.
• Assist customers and healthcare facilities in understanding applicable regulatory requirements related to imaging equipment.
Training & Awareness
• Conduct radiation safety awareness programs and training sessions for employees and service personnel.
• Support development of SOPs, work instructions, and radiation safety procedures.
• Promote a culture of radiation protection, compliance, and workplace safety.
Qualifications and Experience:
• B.E. / B.Tech / Diploma in Biomedical Engineering, Electronics Engineering, Electrical Engineering, Instrumentation Engineering, Medical Electronics, or related discipline.
• AERB Certified Radiation Safety Officer (RSO) certification is mandatory.
• 3–8 years of experience in radiation safety, regulatory affairs, quality compliance, or medical imaging equipment manufacturing.
• Experience handling AERB licensing, regulatory submissions, and compliance documentation.
• Exposure to X-Ray, DR, Mobile DR, C-Arm, Mammography, Fluoroscopy, or CT systems is preferred.
• Experience with BIS certification processes and medical device regulatory compliance will be an added advantage.
Skills and Competencies:
• Strong understanding of radiation physics, radiation protection principles, and safety practices.
• Sound knowledge of AERB regulations, BIS certification requirements, and medical device standards.
• Familiarity with ISO 13485 Quality Management Systems and ISO 14971 Risk Management.
• Strong analytical, documentation, and problem-solving skills.
• Effective communication and coordination skills for interaction with regulatory authorities and cross-functional teams.
• Proficiency in MS Office, ERP systems, and documentation management tools.
• High attention to detail and commitment to safety and regulatory compliance.
Key Performance Indicators (KPIs):
• 100% compliance with AERB licensing and radiation safety regulations.
• Timely completion of regulatory submissions, approvals, and license renewals.
• Successful BIS certification and surveillance audit outcomes.
• Zero major radiation safety incidents or regulatory non-conformities.
• Accuracy and completeness of compliance documentation.
• Timely closure of audit observations and CAPA actions.
• Successful support of product certification and regulatory approval milestones.
• Effective implementation of radiation safety training and awareness programs.
