Medical Device Regulatory Affairs Specialist

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