Regulatory Affairs Submissions Lead
2 weeks 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 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 MDR...
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Regulatory Affairs Manager
1 week 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
1 week 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 weeks 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 weeks ago
Faridabad, Haryana, India, Haryana 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 Compliance Officer
2 weeks 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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Medical Affairs
3 days ago
Faridabad, India OneOrg.AI | Business AI Full timeMedical Affairs - Evidence ResearchEvidence AI Platform for DoctorsRole: Medical Affairs – Evidence ResearchCompany: OneRx.ai (OneOrg.AI)Location: India - GurgaonType: Full-TimeDomain: Evidence Intelligence | Clinical Research | Medical AIJoining: Immediate joiners preferredAbout OneRx.aiOneRx.ai is India’s first Evidence Intelligence...
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Medical Affairs
3 weeks ago
Faridabad, India OneOrg.AI | Business AI Full timeMedical Affairs Co-Founder – Evidence AI Platform (OneRx.ai)Location: Gurgaon, India | Full -Time | Evidence Intelligence & Ai HealthTechAbout OneRx.aiOneRx.ai is India’s first Evidence Intelligence Platform for Doctors , being built on trusted sources like ICMR, NEJM,, and PubMed among others— powered by a medical-grade AI engine.We are a...
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Medical Affairs
6 days ago
Faridabad, India OneOrg.AI | Business AI Full timeMedical Affairs Co-Founder – Evidence AI Platform (OneRx.Ai) 📍 Location: Gurgaon, India | 💼 Full -Time | 🧠 Evidence Intelligence & Ai HealthTech About OneRx.Ai OneRx.Ai is India’s first Evidence Intelligence Platform for Doctors, being built on trusted sources like ICMR, NEJM,, and PubMed among others— powered by a medical-grade AI engine. We...
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Lead Toxicologist
4 weeks ago
Faridabad, India Aal Biosciences Research Pvt Ltd Full timeAbout Us From discovery to regulatory submission we ensure every study meets the highest standards of data integrity reproducibility and ethical conduct As a multidisciplinary Contract Research Organization CRO we provide end-to-end preclinical analytical and regulatory support for pharmaceuticals biopharmaceuticals medical devices cosmetics nutraceuticals...
