Job Description

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.