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Radiation Safety Executive

Radiation Safety Executive

MerilKota, IN
17 days ago
Job description

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
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