Senior Manager Regulatory Affairs

3 weeks ago

Bengaluru, India One of the Leading Surgical solutions and Medtech Company Full time

Our client is one one of the pioneers and trusted surgical solutions and medtech companies. They export to more than 80 countries worldwide and collaborate with hospitals, governments, and healthcare systems worldwide to strengthen surgical ecosystems and improve patient lives. Primary Role: The QA & Regulatory Affairs Manager leads and oversees all regulatory and quality assurance activities within the company, ensuring that all products comply with local and international medical device regulations. A core aspect of this position is to build and implement a full Quality Management System (QMS) compliant with ISO 13485:2016, and to ensure regulatory readiness for global markets including India (CDSCO), US (FDA 510(k)), and EU (MDR CE marking). Key responsibilities: The role is responsible for developing and executing regulatory strategies, managing submissions and approvals, and maintaining strong relationships with health authorities, notified bodies, and certification agencies to support product launches and lifecycle management. - Quality Management System (QMS): ISO 13485:2016; risk management (ISO 14971) - Design Controls & Documentation: Software/ System Requirement Specifications (SRS), Design History Files (DHF), Device Master Records (DMR), and Risk Management Files. - Regulatory Strategy & Submissions: CDSCO manufacturing license & device registration, US FDA 510(k) submissions, and EU MDR CE Marking. - Compliance & Regulatory Intelligence: Ensure continuous compliance with national and international regulations, including CDSCO, USFDA, EMA, MHRA, WHO, and TGA. - Cross-Functional Collaboration: Work closely with R&D, QA/QC, Production, and Supply Chain teams to compile and validate data required for submissions and ongoing compliance. - Post-Market Surveillance (PMS): Support the establishment of a PMS system including complaint handling, vigilance reporting, and trend analysis. Candidate Profile Education & Experience - Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biomedical Engineering, or a related field. - 8–15 years of experience in Regulatory Affairs within the medical device or combination product sector, with demonstrated managerial experience. - Proven track record in building or managing ISO 13485-compliant QMS. - Hands-on experience with global regulatory submissions (US FDA 510(k), EU MDR, CDSCO, TGA, ROW). - Strong knowledge of ISO 13485, ISO 14971, and EU MDR 2017/745 frameworks.

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