Radiation Safety Officer

About the Role

We are seeking a Radiation Safety Officer dedicated to ensuring regulatory compliance and maintaining radiation safety standards for medical imaging devices including X-Ray, Mobile X-Ray, Digital Radiography, C-Arm, Mammography, Fluoroscopy, and CT systems at our facility in Vapi, Gujarat. This role involves overseeing radiation protection programs, managing Atomic Energy Regulatory Board (AERB) approvals, supporting Bureau of Indian Standards (BIS) certification processes, and guaranteeing adherence to national and international guidelines across the product lifecycle.

Key Responsibilities

• Implement and oversee radiation safety initiatives within R&D, manufacturing, testing, validation, and service operations.
• Perform radiation leakage tests, area surveys, shielding analysis, and monitor workplace radiation levels.
• Ensure personnel radiation exposure is maintained within AERB prescribed limits and maintain detailed dosimetry and radiation records.
• Calibrate and manage radiation measurement equipment including survey meters and dosimeters for accurate monitoring.
• Conduct radiation risk assessments and facilitate corrective measures for identified safety concerns.
• Coordinate and manage AERB licensing processes, approvals, registrations, amendments, and renewals for radiation-emitting medical devices.
• Prepare and manage submission documents, liaise with regulatory bodies during audits and inspections, and ensure timely closure of compliance observations.
• Support BIS certification efforts by coordinating with accredited laboratories, preparing technical documentation, and tracking regulatory changes.
• Assist in product safety through validation activities, design reviews, hazard analysis, and risk management related to radiation-emitting devices.
• Maintain comprehensive records supporting radiation safety, licensing, calibration, and compliance activities to aid internal and external audit processes.
• Collaborate across teams including R&D, Quality Assurance, Manufacturing, Testing, Service, and Regulatory Affairs to facilitate compliance and radiation safety objectives.
• Conduct trainings and awareness sessions to promote a culture of radiation safety and compliance among employees and service staff.

Qualifications and Experience

• B.E. / B.Tech / Diploma in Biomedical, Electronics, Electrical, Instrumentation Engineering, Medical Electronics, or related field.
• Mandatory AERB Certified Radiation Safety Officer (RSO) certification.
• 3 to 8 years of experience in radiation safety, regulatory affairs, quality compliance, or manufacturing of medical imaging equipment.
• Hands-on experience with AERB licensing, regulatory submissions, and compliance documentation.
• Preferred familiarity with X-Ray, Digital Radiography, Mobile DR, C-Arm, Mammography, Fluoroscopy, or CT technologies.
• Knowledge of BIS certification protocols and medical device regulatory compliance is an advantage.

Skills and Competencies

• Comprehensive understanding of radiation physics, and radiation protection principles.
• In-depth knowledge of AERB regulations, BIS certification requirements, and medical device standards.
• Experienced with ISO 13485 Quality Management Systems and ISO 14971 Risk Management standards.
• Strong analytical, documentation, and problem-solving aptitude.
• Excellent communication and coordination skills for effective interaction with regulatory bodies and cross-functional teams.
• Proficiency in MS Office, ERP platforms, and document management tools.
• High attention to detail and rigorous commitment to safety and compliance.

Performance Metrics

• Ensure full adherence to AERB licensing and radiation safety regulations.
• Complete regulatory submissions, licensing approvals, and renewals within stipulated timelines.
• Achieve successful BIS certification and surveillance audit results.
• Prevent major radiation safety incidents and regulatory breaches.
• Maintain precise and comprehensive compliance documentation.
• Close audit observations and corrective actions promptly.
• Support product certification and regulatory milestones effectively.
• Implement and sustain radiation safety training and awareness programs successfully.