Regulatory Affairs Specialist
7 days ago
Role Overview:Responsible for preparing, reviewing, and maintaining regulatory submissions and product registrations to ensure compliance with CDSCO, US FDA, and EU MDR requirements.Key Responsibilities:Prepare and submit regulatory dossiers for product approvals and renewals.Develop and maintain Technical Files, DMR, and DHF .Ensure compliance with CDSCO, FDA 21 CFR Part 820, and EU MDR .Review labeling, IFUs, and promotional materials for compliance.Monitor regulatory updates and standards relevant to medical devices.Support internal and external audits , providing necessary documentation.Collaborate with R&D, QA, and manufacturing teams for regulatory input.Qualifications:B.Pharm / M.Pharm / M.Sc (Regulatory Affairs, Biotechnology, or Life Sciences).Minimum 6 years’ experience in Regulatory Affairs for medical devices.Strong knowledge of device registration process and QMS standards .Experience interacting with Notified Bodies / Regulatory Authorities preferred.
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Regulatory Affairs Specialist
2 weeks ago
Delhi, India Concept Medical Full timeAbout Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...
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Regulatory Affairs Specialist
2 weeks ago
Delhi, India Concept Medical Full timeAbout Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in...
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Regulatory Affairs Specialist
5 days ago
Delhi, India Gentell Full timeGentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life.Our success is a result of the...
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Regulatory Affairs Specialist
5 days ago
New Delhi, India Gentell Full timeGentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life.Our success is a result of the...
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Quality and Regulatory Affairs Specialist
1 week ago
Delhi, NCR, Noida, India Saraca Solutions Full time ₹ 4,00,000 - ₹ 8,00,000 per yearWe are seeking a highly skilled Regulatory and Clinical Affairs Specialist with expertise in regulatory compliance for medical devices across the EU, India, and the US.Clinical EvolutionMedical WritingTechnical Documentation
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Regulatory Affairs Specialist
2 weeks ago
Delhi, India Dr. Reddy's Laboratories Full timeJob Summary We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
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Regulatory Affairs Officer
4 days ago
Delhi, India NKG ADVISORY BUSINESS AND CONSULTING SERVICES PVT LTD Full time**Job Title: Cosmetics Regulatory Affairs Specialist - Delhi** Key Responsibilities: - Conduct regulatory assessments of cosmetic products to ensure compliance with relevant regulations and guidelines - Prepare and submit regulatory dossiers to the appropriate authorities for import registration of cosmetics under COS 02 and COS 04 categories - Stay...
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Regulatory Affairs Specialist
2 weeks ago
Delhi, Delhi, India Masimo Full time ₹ 5,00,000 - ₹ 12,00,000 per yearThe primary role for the Regulatory Affairs Specialist is to manage end to end Regulatory Submissions & Compliance for Masimo India teamPrepare, draft, and compile 510(k)/any other applicable Premarket Notifications and related FDA submissions.Support domestic and international product filings and registrations, including maintenance of EU Technical Files,...
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Regulatory Affairs Specialist
4 days ago
Bengaluru, Delhi, NCR, Vellore, India Airvin Skills Full time ₹ 2,00,000 - ₹ 8,00,000 per yearEWe are looking for a passionate and detail-oriented Regulatory Affairs Specialist (Fresher) to join our life sciences and healthcare compliance team. The ideal candidate will be responsible for assisting in the preparation, review, and submission of regulatory documents and ensuring adherence to national and international standards for product approval and...
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Regulatory Affairs Specialist Oligonucleotides
2 weeks ago
New Delhi, India Dr. Reddy's Laboratories Full timeJob SummaryWe are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...