Regulatory Affairs Executive

Job Title:

Regulatory Affairs Executive – Regulatory & Safety (Radiology & Imaging Systems)

Department:

Regulatory & Safety – Radiology Division

Location:

Vapi, Gujarat

Reports To:

Manager / Senior Manager – Regulatory & Safety

Job Purpose:

To manage and coordinate regulatory documentation and compliance activities for radiology and imaging systems such as X-Ray, C-Arm, Digital Radiography (DR), and CT equipment, ensuring adherence to BIS, AERB, NABL, and international regulatory standards applicable to medical device manufacturing.

Key Responsibilities:

1. Regulatory Documentation and Compliance

• Prepare, review, and maintain documentation for product approvals and certifications from BIS (Bureau of Indian Standards), AERB (Atomic Energy Regulatory Board), and NABL (National Accreditation Board for Testing and Calibration Laboratories).
• Ensure all technical files, QA test reports , and compliance certificates are updated and aligned with current regulatory norms.
• Coordinate the submission and follow-up of applications for new product registrations, renewals, and amendments.
• Track changes in regulatory requirements and ensure timely updates to internal documentation and procedures.

2. Product and Process Compliance

• Ensure that manufacturing, testing, and quality processes for X-Ray, C-Arm, DR, and CT system assemblies comply with applicable regulatory standards.
• Collaborate with cross-functional teams to maintain compliance with ISO 13485, BIS 13450, and IEC 60601, QA Test & ISO 17025 series standards.
• Support internal reviews and audits to ensure readiness for inspections by AERB, BIS, or NABL authorities.
• Assist in preparing Technical Construction Files (TCF) and Declaration of Conformity (DoC) documents.

3. Coordination with Regulatory Authorities

• Liaise with regulatory bodies, certification agencies, and notified laboratories for product registration, testing, and approval activities.
• Ensure all correspondence with government or certification agencies is timely, accurate, and professionally maintained.
• Coordinate with testing laboratories for evaluation and compliance verification of imaging devices.

4. Documentation Control and Audits

• Manage regulatory documentation databases and ensure document traceability, version control, and secure archiving.
• Support internal and external audits related to regulatory compliance, ISO 13485, and GMP.
• Maintain audit readiness and participate in inspections by regulatory authorities.
• Prepare and circulate periodic compliance status reports to management.

5. Cross-Functional Support

• Collaborate with Design, Quality, Production, and Radiation Safety teams to ensure all regulatory requirements are met during product design, manufacturing, and testing.
• Support the preparation of technical dossiers, validation reports, and test summaries for regulatory submissions.
• Provide training and guidance to team members on regulatory documentation and compliance updates.

Qualifications and Experience:

• B.E. / B.Tech/Diploma in Electronics or Biomedical Engineering.
• 3–5 years (or more) of experience in Regulatory Affairs, Documentation, or Compliance within a medical device or imaging equipment manufacturing environment.
• Strong understanding of BIS, AERB, NABL, ISO 13485, GMP, and IEC 60601 standards.
• Experience with X-Ray, C-Arm, DR, and CT systems documentation and RS-QADXE compliance will be preferred.

Skills and Competencies:

• Excellent understanding of regulatory frameworks and documentation protocols for medical devices.
• Strong attention to detail and accuracy in documentation and data management.
• Good coordination and communication skills for interaction with authorities and internal teams.
• Proficient in MS Office, ERP, and document control systems.
• Strong analytical, organizational, and follow-up skills.
• Ability to interpret technical and regulatory guidelines effectively.

Key Performance Indicators (KPIs):

• Timely submission and renewal of regulatory licenses and certifications
• 100% compliance with BIS, AERB, and NABL requirements
• Accuracy and completeness of regulatory documentation
• Successful audit outcomes with minimal observations
• Effective coordination with authorities and testing agencies