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