Radiological Safety Officer (RSO)

1. Radiation Safety Officer Responsibilities 

• Serve as the designated and AERB-approved Radiation Safety Officer for the Bengaluru manufacturing facility. Based on the approval letter, the RSO is expected to perform duties in accordance with the Atomic Energy (Radiation Protection) Rules and related AERB requirements, submit required reports, and promptly report radiation safety events to AERB. 

• Ensure compliance with applicable Atomic Energy Act requirements, Atomic Energy (Radiation Protection) Rules, AERB Safety Codes, Guides, and associated regulatory requirements. 

• Submit periodic radiation safety reports and regulatory updates to AERB as required. 

• Promptly report radiation safety incidents, unusual occurrences, deviations, or regulatory concerns to AERB and company management. 

• Serve as the primary site contact during radiation safety inspections and regulatory interactions. 

• Maintain radiation safety documentation, monitoring records, personnel dosimetry records, training records, and licensing documentation. 

• Support implementation and maintenance of an effective radiation protection program across the site. 

2. AERB Licensing and Regulatory Compliance 

• Manage AERB licenses, registrations, approvals, permits, and authorizations required for the Bengaluru manufacturing facility. 

• Support facility registration, license renewals, amendments, modifications, and expansion activities. 

• Prepare and submit regulatory applications, technical dossiers, responses to deficiency letters, and supporting documentation. 

• Monitor and assess regulatory changes and determine potential impacts to business operations. 

• Establish and maintain a productive working relationship with AERB. 

• Coordinate and manage AERB inspections, audits, and post-inspection commitments. 

• Ensure timely regulatory reporting and maintenance of all required approvals. 

3. Radiation Safety Import and Export Licensing 

• Manage and support AERB import licensing activities related to radiation-emitting products, components, accessories, sources, and associated equipment. 

• Coordinate with Supply Chain, Manufacturing, Logistics, Service, and Regulatory Affairs teams to ensure regulatory approvals are obtained prior to shipment. 

• Review imports and exports for compliance with applicable AERB requirements. 

• Support import permit applications, amendments, renewals, and related regulatory submissions. 

• Maintain records of imports, exports, transfers, inventory, and disposition of regulated items. 

4. Manufacturing and Facility Support 

• Provide radiation safety oversight for Halcyon manufacturing, assembly, integration, testing, validation, and acceptance activities. 

• Evaluate facility changes, engineering modifications, and process changes from a radiation safety perspective. 

• Participate in risk assessments and implementation of radiation protection controls. 

• Support commissioning, qualification, and validation activities involving radiation-generating equipment. 

• Review and approve radiation safety aspects of site procedures, work instructions, and operational controls. 

• Support future manufacturing expansion projects and facility readiness activities. 

5. Radiation Worker Protection Program 

• Manage and maintain the site's Personnel Monitoring Program. 

• Ensure all radiation workers receive appropriate monitoring, training, qualification, and authorization. 

• Review occupational exposure results and investigate any abnormal exposures. 

• Maintain exposure records in accordance with regulatory requirements. 

• Implement and promote ALARA (As Low As Reasonably Achievable) principles. 

• Coordinate with approved dosimetry providers and maintain compliance with personnel monitoring requirements. 

6. Radiation Safety Training 

• Develop, implement, and maintain site radiation safety training programs. 

• Ensure all relevant personnel receive initial and periodic refresher radiation safety training. 

• Conduct awareness programs and training for radiation workers and other impacted functions. 

• Maintain training records and competency documentation. 

• Provide regulatory and radiation safety guidance to cross-functional teams. 

7. Inspections, Audits and Continuous Improvement 

• Lead preparedness activities for AERB inspections, customer audits, internal audits, and regulatory assessments. 

• Support Quality Management System requirements associated with radiation safety activities. 

• Identify compliance gaps and drive corrective and preventive actions (CAPA). 

• Monitor compliance metrics and support continuous improvement initiatives. 

• Participate in management reviews and compliance governance forums. 

8. Emergency Preparedness and Incident Response 

• Support development and maintenance of radiation emergency response plans. 

• Participate in emergency drills, investigations, and response activities. 

• Provide technical expertise during radiation-related incidents. 

• Ensure appropriate notification, reporting, investigation, and corrective actions are completed. 

9. Medical Device Regulatory Support (Preferred) 

• Support Regulatory Affairs activities related to the Central Drugs Standard Control Organization (CDSCO), Medical Device Rules (MDR) 2017, and associated guidance documents. 

• Provide support for device registration, manufacturing license applications, license amendments, renewals, and post-approval regulatory activities where radiation safety expertise is required. 

• Coordinate with Regulatory Affairs colleagues to support inspections, audits, and regulatory submissions involving radiation-emitting medical devices. 

• Monitor and assess regulatory developments related to CDSCO and provide input regarding potential impacts on manufacturing operations and product compliance. 

Required Qualifications 

• Master's Degree in Medical Physics, Radiation Physics, Radiological Physics, Nuclear Physics, or equivalent recognized qualification. 

• Current AERB-approved Radiation Safety Officer certification or eligibility to be approved as an RSO by AERB. 

• Minimum 5 years of relevant experience in radiation safety, medical physics, radiation regulatory affairs, or related disciplines. 

• Demonstrated experience working with AERB regulations and licensing processes. 

• Strong understanding of radiation protection principles, radiation monitoring, dosimetry, and radiation-generating equipment. 

• Experience supporting manufacturing, healthcare, medical device, radiotherapy, or industrial radiation environments. 

• Strong communication, interpersonal, and stakeholder management skills.