Senior Manager Regulatory Affairs
3 weeks ago
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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Regulatory Affairs Manager
2 weeks ago
Bengaluru, Karnataka, India Kumar Organic Products Full timeJob Title: Regulatory Affairs ManagerDepartment: Regulatory Affairs / Quality & ComplianceReporting to: Head Regulatory AffairsJob Purpose:To lead and oversee all regulatory affairs activities, ensuring company products comply with applicable local and international regulatory requirements. The role involves developing regulatory strategies, managing...
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Senior Manager Regulatory Affairs
3 weeks ago
Bengaluru, India One of the Leading Surgical solutions and Medtech Company Full timeOur 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...
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Senior Manager Regulatory Affairs
3 weeks ago
Bengaluru, India One of the Leading Surgical solutions and Medtech Company Full timeOur 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...
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Senior Manager Regulatory Affairs
3 weeks ago
Bengaluru, India One of the Leading Surgical solutions and Medtech Company Full timeOur 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...
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Senior Manager Regulatory Affairs
3 weeks ago
Bengaluru, India One of the Leading Surgical solutions and Medtech Company Full timeOur 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...
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Senior Manager Regulatory Affairs
3 weeks ago
Bengaluru, India One of the Leading Surgical solutions and Medtech Company Full timeOur 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...
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Senior Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India AliveCor Full time US$ 1,00,000 - US$ 1,50,000 per yearDescriptionAt AliveCor, we imagine a healthier world powered by access to personalized intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the worlds heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered...
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Senior Manager, Global Regulatory Affairs
5 days ago
Bengaluru, Karnataka, India 50skills Full time ₹ 20,00,000 - ₹ 25,00,000 per yearWe are looking for a Senior Manager to join our Global Regulatory Affairs team, specializing in Lifecycle Management (LCM) for Chemistry, Manufacturing, and Controls (CMC). CMC ensures that pharmaceutical products are consistently produced and meet quality standards during development and throughout their lifecycle.In this role, you will develop global...
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Regulatory Affairs Associate
10 hours ago
Bengaluru, India ANRGI TECH Pvt. Ltd. Full timeJob Description Job Title: Regulatory Affairs Associate – Authoring. Role detailed classification Regulatory Affairs Authoring Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – Authoring to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring...
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Regulatory Affairs Associate
10 hours ago
Bengaluru, India ANRGI TECH Pvt. Ltd. Full timeJob Title: Regulatory Affairs Associate – Authoring. Role detailed classification Regulatory Affairs Authoring Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – Authoring to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring and/or other...
