Regulatory Affairs Specialist
3 weeks ago
About 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 Netherlands to further our mission of saving lives and improving patient care.Job Summary:We are seeking a dedicated and knowledgeable Regulatory Specialist to ensure our medical devices meet local and international regulatory standards. The ideal candidate will have extensive knowledge of CDSCO, ISO, FDA, and other regulatory requirements, ensuring the highest standards of safety and efficacy for our products.Key Responsibilities:- Develop regulatory strategies for new/existing products.- Ensure compliance with local/international regulations (CDSCO, ISO, FDA).- Prepare and submit regulatory submissions.- Monitor regulatory developments and adjust strategies.- Liaise with regulatory bodies and internal teams for compliance.- Conduct audits and maintain up-to-date knowledge of regulatory requirements.Required Qualifications:- Bachelor’s degree in a scientific discipline.- 5 to 7 years’ experience in regulatory affairs within the medical device industry.- In-depth knowledge of CDSCO, ISO, FDA standards.- Experience with regulatory submissions and medical device development.- Excellent communication, organizational, and project management skills.Preferred Qualifications:- Advanced degree (Master’s/Ph.D.).- Professional certification in regulatory affairs (RAC).
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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
2 weeks 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
2 weeks 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
2 weeks 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
7 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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Regulatory Affairs Officer
2 weeks 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
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
3 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
3 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...