Quality Assurance Regulatory Affairs Manager
3 weeks ago
Key Responsibilities: Location: Pune Regulatory Compliance: Ensure adherence to ISO 13485, EN ISO 13485, USFDA, SFDA, UKCA, and CE certification standards. Quality Management Systems (QMS): Implement and maintain robust QMS to comply with regulatory standards. Technical Documentation: Prepare and review technical files for regulatory submissions, ensuring accuracy and completeness. Risk Management: Apply ISO 14971 guidelines for risk assessment and mitigation in the product lifecycle. Audits & Inspections: Conduct internal audits, manage external regulatory audits, and ensure readiness for inspections by authorities such as FDA, MHRA, and SFDA. Change Management: Manage post-market surveillance, complaint handling, and CAPA (Corrective and Preventive Actions) processes. Regulatory Strategy: Develop and implement compliance roadmaps tailored to various regulatory environments and markets. Communication & Collaboration: Coordinate with regulatory bodies, notified bodies, and cross-functional teams to ensure seamless compliance.Mandatory Skills: In-depth expertise in ISO 13485, EN ISO 13485, USFDA, SFDA, UKCA, and CE certification processes. Strong understanding of Quality Management Systems (QMS) and experience in their implementation and maintenance. Proficient in technical documentation, particularly for regulatory submissions. Hands-on experience in risk management practices, particularly ISO 14971. Demonstrated ability to manage internal and external audits and liaise with regulatory authorities. Experience in change management processes including CAPA, post-market surveillance, and complaints management. Ability to develop and execute regulatory strategy for different markets. Strong communication skills with a proven ability to collaborate effectively with cross-functional teams and external regulatory bodies.Desirable Experience: Prior experience managing audits and regulatory submissions with bodies such as FDA, MHRA, SFDA, etc. Familiarity with software-based QMS tools and electronic documentation systems. Strong problem-solving skills and ability to stay updated with evolving industry regulations. Experience: 5-7 years of experience in Quality Assurance and Regulatory Affairs, particularly in the medical device industry. Interested candidates can share their CV atruchi.c@myfrido.com.
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Torrent Pharmaceuticals
2 days ago
New Delhi, India TORRENT PHARMACEUTICALS LTD Full timeWe are looking for a detail-oriented Senior Quality Assurance Officer (RA) to support our regulatory operations and ensure continued compliance with applicable regulatory requirements. The role directly reports to the Regulatory Affairs Manager and requires European Regulatory Affairs knowledge to support daily operations as well as projects.Key...
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Regulatory Affairs Manager
4 weeks ago
New Delhi, India Ixoreal Biomed Full timeAbout the Company : Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ yearsof Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...
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Regulatory Affairs Associate
2 weeks ago
New Delhi, India Aurolab Full timeJob Summary:A Regulatory Affairs Associate in the medical device industry supports the development, registration, and compliance of medical devices throughout their lifecycle. This entry-to-mid- level role ensures products meet regulatory standards set by bodies such as the FDA (U.S.), EU MDR (Europe), and other international authorities. The associate works...
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Regulatory Affairs Manager
4 weeks ago
Delhi, India Ixoreal Biomed Full timeAbout the Company: Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts. Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...
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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...
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Vacancy for Regulatory Affairs at Delhi Ncr
1 week ago
Delhi, India RIGHT STAFF Full timeGreetings from Right Staff One of our client who are into Medical Devices Are looking for a Regulatory Affairs person at Delhi NCR Job Description - **Experience minimum 5 Years and above compulsory** Designation - Regulatory Affairs/QA Affairs Time - Day Shift Location - Delhi NCR **Responsibilities**: - 1. Identify regulatory and post market...
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PRG Pharma
2 weeks ago
New Delhi, India PRG Pharma Pvt Ltd - India Full timeTitle: Assistant Manager Regulatory AffairsLocation: Netaji Subhash Place, Pitampura, DelhiExperience Required: 3- 4 YearsDepartment: Regulatory AffairsEmployment Type: Full-TimeAbout the Role:The Assistant Manager Regulatory Affairs will be responsible for managing regulatory submissions, ensuring compliance with national and international regulatory...
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Regulatory Affairs Manager
4 weeks ago
Delhi, India Ixoreal Biomed Full timeAbout the Company:Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.Title: Manager/Senior Manager- Global Regulatory AffairsExperience:8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements, Herbal...
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Regulatory Affairs Manager
4 weeks ago
Delhi, India Ixoreal Biomed Full timeAbout the Company :Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.Title: Manager/Senior Manager- Global Regulatory AffairsExperience:8–12+ yearsof Regulatory Affairs experience in Nutraceuticals, Dietary Supplements, Herbal...
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Regulatory Affairs Officer
19 hours 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,...
