Regulatory Affairs Executive

Job Title:Regulatory Affairs Executive – Regulatory & Safety (Radiology & Imaging Systems)Department:Regulatory & Safety – Radiology DivisionLocation:Vapi, GujaratReports To:Manager / Senior Manager – Regulatory & SafetyJob 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