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