Regulatory Affairs Specialist
5 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 compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.).- Ensure compliance with ISO 13485, EU MDR 2017/745, US FDA 21 CFR Part 820, and local regulatory guidelines.- Review labeling, IFUs, and promotional materials for compliance.- Manage product registration, renewals, and post-market submissions.- 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
2 weeks ago
Faridabad, India Polymed Full time**Regulatory Affairs**: - From 0 to 5 year(s) of experience - ₹ Not Disclosed by Recruiter - Faridabad ( Ballabhgarh)- or - To coordinate with marketing for collecting, analyzing and making PMS, PSUR & PMCF report for various products - Registration of all devices on Eudamed and uploading required documents on eudamed - To search relevant literatures...
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Regulatory Affairs Specialist
3 days ago
Faridabad, India vueverse. Full timeRole 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 compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.).Ensure compliance with ISO 13485, EU MDR...
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Regulatory Affairs Specialist
2 days ago
Faridabad, India vueverse. Full timeRole 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 compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.).Ensure compliance with ISO 13485, EU MDR...
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Regulatory Affairs Specialist
2 days ago
Faridabad, India vueverse. Full timeRole 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 compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.).Ensure compliance with ISO 13485, EU MDR...
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Regulatory Affairs Specialist
2 days ago
faridabad, India vueverse. Full timeRole 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 compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.).Ensure compliance with ISO 13485, EU MDR...
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Regulatory Affairs Specialist
2 days ago
Faridabad, India vueverse. Full timeRole 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 compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.). - Ensure compliance with ISO 13485, EU...
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Regulatory Affairs Specialist
1 day ago
Faridabad, India vueverse. Full timeRole 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 compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.).- Ensure compliance with ISO 13485, EU MDR...
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Regulatory Affairs Specialist
1 day ago
Faridabad, India vueverse. Full timeRole 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 compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.). Ensure compliance with ISO 13485, EU MDR...
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Regulatory Affairs Specialist
5 hours ago
Faridabad, India vueverse. Full timeRole 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 compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.). Ensure compliance with ISO 13485, EU MDR...
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Quality Assurance Regulatory Affairs
7 days ago
Faridabad, Haryana, India Mancraft Consulting Full time ₹ 6,00,000 - ₹ 18,00,000 per yearJob Description:Description :Regulatory Compliance:Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking).Ensure that products meet all regulatory requirements and maintain relevant documentation.Quality Assurance:Develop and implement quality assurance processes and procedures.Conduct internal audits and...
