Regulatory Affairs Specialist
18 hours 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 compileregulatory submissions(e.g., Device Master File, Technical File, 510(k), CE marking, etc.). Ensure compliance withISO 13485, EU MDR 2017/745, US FDA 21 CFR Part 820 , and local regulatory guidelines. Reviewlabeling, IFUs, and promotional materialsfor compliance. Manage productregistration, renewals, and post-market submissions . Monitorregulatory updates and standardsrelevant to medical devices. Supportinternal 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 inRegulatory Affairsfor medical devices. Strong knowledge ofdevice registration process and QMS standards . Experience interacting withNotified Bodies / Regulatory Authoritiespreferred.
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Regulatory Affairs Specialist
7 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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Regulatory Affairs Specialist
3 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
3 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
7 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 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...
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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...
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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
3 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
2 days ago
Delhi, India NKG ADVISORY BUSINESS AND CONSULTING SERVICES PVT LTD Full timeRegulatory Affairs Specialist - Legal Metrology and EPR India **Responsibilities**: Regulatory Compliance: Stay up-to-date with the latest Legal Metrology and EPR regulations in India. Ensure that all products and processes comply with these regulations. Documentation: Prepare and maintain all necessary documentation required for regulatory submissions,...
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New Delhi, India Danaher Full timeThis job is with Danaher, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Wondering what’s within Beckman Coulter Diagnostics? Take a closer look. At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and...
