Regulatory Affairs Specialist
18 hours ago
Location: Bengaluru / HybridExperience: 5 - 8 yearsOverall Package: 8 - 10 LPARole Summary:The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working cross-functionally with design, quality, clinical, and manufacturing teams to ensure regulatory compliance throughout the product lifecycle and to maintain an effective Quality Management System (QMS) aligned with ISO 13485 and other applicable standards.Key Responsibilities:- Prepare, review, and submit regulatory dossiers and applications to CDSCO, including: - Manufacturing and import licenses, Test licenses, Device registration dossiers,Post-approval variations and renewals - Prepare Technical Documentation and Design Dossiers as per EU, India requirements. - Prepare US FDA submissions, including: - 510(k), PMA, De Novo, and Q-Submission documentation. - Address queries, deficiencies, and audits of Notified Bodies, CDSCO, and FDA reviewers - Support implementation and maintenance of ISO 13485:2016, 21 CFR Part 820 (QMSR), and MDSAP requirements. - Assist in creation and control of SOPs, CAPA, internal audits, supplier audits, risk management, and document control. - Participate in management reviews and regulatory audits. - Ensure QMS integration with regulatory submissions (Device Master Record, Design History File).Qualifications & Required Skills:- Bachelor’s or Master’s degree in Biomedical Engineering, Pharmacy, any Life Sciences, or its related field. - 5 - 8 years of experience in Regulatory Affairs for medical devices. - Hands-on experience and good understanding with: - CDSCO submissions and India Medical Device Rules (IMDR 2017). - EU MDR Technical File (STED) / Annex II–III documentation. - US FDA submissions 510(k)/PMA. - ISO 13485, 21 CFR 820, and MDSAP QMS frameworks. - Familiarity with risk management (ISO 14971), software as a medical device (SaMD), and clinical evaluation requirements. - Strong understanding of labeling, vigilance, and post-market compliance. - Excellent documentation, communication, and stakeholder management skills.Preferred / Desirable:- Experience working with consulting firms or global OEMs. - Exposure to IVD devices, Combination products, or digital health/SaMD. - Certification in Regulatory Affairs (RAC) or Quality (CQE, Lead Auditor) is an added advantage.
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