Regulatory Compliance Manager
3 hours ago
Regulatory Compliance ManagerThe primary role involves overseeing the preparation, review, and maintenance of regulatory submissions and product registrations to ensure adherence to relevant standards.Key Responsibilities:Compile and manage regulatory submissions, encompassing documentation such as Device Master Files and Technical Files.Ensure compliance with international regulations including ISO 13485, EU MDR 2017/745, US FDA 21 CFR Part 820, and local guidelines.Verify labeling, Instructions for Use (IFUs), and promotional materials for regulatory compliance.Oversee product registration, renewals, and post-market submissions to meet regulatory requirements.Maintain awareness of updates and changes in medical device regulations.Support internal and external audits by providing necessary documentation and expertise.
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Regulatory Affairs Manager
3 days ago
Faridabad, Haryana, India Polymed Full time ₹ 4,00,000 - ₹ 12,00,000 per yearJob Title: Manager (RA)Location: FaridabadDepartment: Regulatory Affairs (RA)Job Overview:We are seeking a meticulous Documentation Officer / Manager to manage regulatory documentation and ensure compliance with ISO 13485, EU MDR, FDA, and other regulatory standards.Key Responsibilities:Prepare, maintain, and review regulatory documentation as per ISO 13485,...
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Regulatory Affairs Specialist
4 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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Manager - Quality Assurance & Regulatory Affairs
2 weeks ago
Faridabad, Haryana, India Mancraft Consulting Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Description:JD For QARA 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...
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Quality Assurance Regulatory Affairs
1 week 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...
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Regulatory Affairs Specialist
6 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
5 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
5 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
4 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
4 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
1 day ago
Faridabad, India Whatjobs IN C2 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...