Regulatory Affairs Executive - Radiology

Job Title:Regulatory Affairs Executive – Regulatory & Safety (Radiology & Imaging Systems) Department: Regulatory & Safety – Radiology Division Location: Vapi, Gujarat Reports To: Manager / Senior Manager – Regulatory & SafetyJob Purpose: To manage and coordinateregulatory documentation and compliance activitiesforradiology and imaging systemssuch asX-Ray, C-Arm, Digital Radiography (DR), and CT equipment, ensuring adherence toBIS, 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 fromBIS (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 forX-Ray, C-Arm, DR, and CT system assembliescomply with applicable regulatory standards. Collaborate with cross-functional teams to maintain compliance withISO 13485, BIS 13450, and IEC 60601, QA Test & ISO 17025series standards. Support internal reviews and audits to ensure readiness for inspections byAERB, BIS, or NABLauthorities. Assist in preparingTechnical Construction Files (TCF)andDeclaration of Conformity (DoC)documents. 3. Coordination with Regulatory Authorities Liaise withregulatory bodies, certification agencies, and notified laboratoriesfor product registration, testing, and approval activities. Ensure all correspondence with government or certification agencies is timely, accurate, and professionally maintained. Coordinate withtesting laboratoriesfor 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 toregulatory 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 withDesign, Quality, Production, and Radiation Safetyteams 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 inRegulatory Affairs, Documentation, or Compliancewithin amedical device or imaging equipment manufacturingenvironment. Strong understanding ofBIS, AERB, NABL, ISO 13485, GMP, and IEC 60601standards. Experience withX-Ray, C-Arm, DR, and CT systemsdocumentation and RS-QADXE compliance will be preferred.Skills and Competencies: Excellent understanding ofregulatory frameworks and documentation protocolsfor 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 inMS 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

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