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Expert Regulatory Compliance Specialist

2 weeks ago

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Regulatory Affairs Specialist JobWe are seeking a detail-oriented Regulatory Affairs Professional to join our team.The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure compliance with domestic and international regulations across global markets including India, the US, and the EU.This role requires strong coordination skills and a proactive approach to support product registrations, audits, and technical submissions.Key Responsibilities:Conduct gap analysis of existing regulatory and technical documentation.Prepare and maintain regulatory submissions including Device Master Files, Risk Management Files, Design History Files, Clinical Evaluation Reports, and Usability Reports.Draft and update product labeling content such as Instructions for Use (IFUs), implant cards, and declarations to meet global compliance requirements.Support regulatory submissions for India (via CDSCO/SUGAM/NSWS), the US (FDA), the EU (CE marking under MDR), and other applicable markets.Coordinate with cross-functional teams to gather documentation and resolve queries.Assist in preparing and submitting responses for audit-related queries and regulatory inspections.Contribute to regulatory strategy for new product developments and modifications.Requirements:Bachelor's or Master's degree in Pharmaceutical Sciences, Engineering, Biotechnology, Microbiology, or a related life science field.Specialization in Regulatory Affairs or Quality Assurance preferred.1-4 years of industry experience in a Regulatory Affairs role, preferably in medical devices, pharmaceuticals, or life sciences.Exposure to documentation systems and regulatory portals is essential.Skillset:Strong knowledge of regulatory frameworks including ISO 13485, EU MDR, and 21 CFR Part 820.Risk management, design controls, and post-market surveillance.Excellent documentation, analytical, and technical writing skills.Proficient in Microsoft Office Suite and digital documentation platforms.Strong interpersonal skills to collaborate with internal departments and external bodies.