senior regulatory affairs Executive

Job Description

We are seeking a Senior Regulatory Affairs Executive with strong expertise in medical devices. The role involves handling end-to-end regulatory compliance, preparing and submitting dossiers, coordinating with CDSCO, managing product approvals, and ensuring adherence to medical device regulations. Candidate should have good knowledge of MDR, BIS, ISO 13485, and related certifications. Must be capable of independently handling regulatory processes. Key Responsibilities: Preparation & submission of regulatory filings for medical devices Coordination with regulatory authorities (CDSCO, BIS) Handling technical files, clinical data, and product dossiers Keeping up-to-date with regulatory changes Ensuring timely approvals & renewals Requirements: Graduate/Postgraduate in Science, Pharmacy, or related field Knowledge of Indian and international medical device regulations Strong documentation and communication skills Preference: Candidates with experience in Class A, B, C, or D devices approval process. Let me know if you want this customized for LinkedIn or any specific company style. CONTACT - NAINA@9999570297 Job Type: Full-time Pay: ₹35,000.00 - ₹45,000.00 per month Schedule: Day shift Work Location: In person