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