Job Responsibilities - CDSCO Specialist Medical Devices Regulatory Compliance Licensing Manage end-to-end regulatory submissions for medical devices under Medical Device Rules MDR 2017 Handle import manufacture sell distribution license applications through the CDSCO online SUGAM portal Prepare and maintain Device Master File DMF and Plant Master File PMF for Class A-D devices Ensure compliance with CDSCO BIS ISO 13485 GHTF and other regulatory standards Coordinate with notified bodies for audit clearances and regulatory inspections Technical Documentation Submission Management Compile review and submit regulatory dossiers including Form MD-3 5 7 8 14 based on classification Prepare clinical evaluation reports risk management documents and safety efficacy data Support labeling packaging UDI markings and ensure alignment with regulatory guidelines Monitor and update regulatory documentation throughout the product lifecycle Post-Market Surveillance Handle Materiovigilance reporting MvPI adverse events recalls product complaints Maintain PMS reports and Periodic Safety Update Reports PSUR Coordinate corrective preventive actions CAPA with Quality Assurance teams Regulatory Strategy Market Access Assess device classification A B C D and define regulatory pathway timelines risk Monitor regulatory updates issued by CDSCO MoHFW BIS ICMED and global agencies Liaise with internal stakeholders for product registration renewals amendments import licensing test licenses etc Support business teams in launch planning product import distribution authorization tender compliance Stakeholder External Coordination Represent the organization in interactions with CDSCO officials state licensing authorities notified bodies testing labs Coordinate with global RA teams for data consolidation and regulatory alignment Act as regulatory advisor for R D manufacturing marketing and supply chain teams Quality Audit Support Support ISO and CDSCO audits GMP inspections and facility assessments Ensure internal systems meet regulatory expectations and maintain audit-ready documentation Participate in root cause analyses compliance gap closures and process improvement activities