Regulatory affairs specialist
1 day ago
Location: Bengaluru / Hybrid Experience: 5 - 8 years Overall Package: 8 - 10 LPA Role 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 (Sa MD) , 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/Sa MD . Certification in Regulatory Affairs (RAC) or Quality (CQE, Lead Auditor) is an added advantage.
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regulatory affairs
7 days ago
Bengaluru, Karnataka, India Randstad MENA Full time ₹ 40,00,000 - ₹ 1,20,00,000 per yearJob Description Job Details This job offer closes 6 January 2026.SummaryLocation: Bengaluru, Karnataka Company: A client of Randstad India Type: Temporary Posted on: 7 November 2025 Reference Number: JPC Next StepsContact the recruiter Set a job alert Create an account Search jobs Randstad Professional We bring diverse and...
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regulatory affairs
1 week ago
bengaluru, India Randstad Full timeWhat do we offer you? Competitive salary and benefits packageRemote work opportunitiesProfessional development and growth opportunitiesCollaborative and supportive team environmentChance to make a significant impact on a global scaleWork-life balance Who are you?We are looking for a dedicated and experienced Regulatory Affairs Specialist to join our...
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Senior Regulatory Affairs Specialist
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Bengaluru, Karnataka, India AliveCor Full time ₹ 12,00,000 - ₹ 24,00,000 per yearAliveCor seeks a Senior Regulatory Affairs Specialist to join this exciting start-up that is changing the face of mobile health. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing and...
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Regulatory Affairs Specialist
3 days ago
Bengaluru, India NexorTest Technologies Full timeLocation: Bengaluru / Hybrid Experience: 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...
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Regulatory Affairs Specialist
1 day ago
Bengaluru, India NexorTest Technologies Full timeLocation: 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...
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Regulatory Affairs Specialist
8 hours ago
Bengaluru, India NexorTest Technologies Full timeLocation: 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...
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Regulatory Affairs Specialist
2 days ago
Bengaluru, India NexorTest Technologies Full timeLocation: Bengaluru / Hybrid Experience: 5 - 8 years Overall Package: 8 - 10 LPA Role 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...
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Regulatory Affairs Specialist
20 hours ago
Bengaluru, India NexorTest Technologies Full timeLocation: Bengaluru / Hybrid Experience: 5 - 8 years Overall Package: 8 - 10 LPA Role 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...
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Regulatory Affairs Specialist
13 hours ago
Bengaluru, India NexorTest Technologies Full timeLocation: Bengaluru / Hybrid Experience: 5 - 8 years Overall Package: 8 - 10 LPA Role 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...
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Regulatory Affairs Specialist
8 hours ago
Bengaluru, India NexorTest Technologies Full timeLocation: Bengaluru / Hybrid Experience: 5 - 8 years Overall Package: 8 - 10 LPA Role 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...
