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