Quality Assurance Regulatory Affairs Manager Frido

5.0 - 7.0 years

0 Lacs

pune, maharashtra, india

On-site

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 surveilla...

Posted 2 weeks ago

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Regulatory Affairs Executive Halma plc

3.0 - 5.0 years

0 Lacs

bengaluru, karnataka, india

On-site

About Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the boundaries of science and technology. For the last 42 years, the combination of our purpose, strategy, people, DNA and sustainable business model has resulted in record long-term growth in revenues and profits and an increase in dividend by ? 5% every year an achievement unrivalled by any company listed on the London Stock Exchange. Why join us ...

Posted 1 month ago

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Qa Head Hemix Hr Solutions

10.0 - 12.0 years

15 - 20 Lacs

Vadodara

Work from Office

The candidate should be M.Sc. (Preferably Microbiology) / M.Pharm/Quality Assurance) with at least 10 /12 years of relevant experience in medical devices industry. IPQA, QMS, Validation, compliance , QA related to its processes and strategy.

Posted 4 months ago

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Regulatory Affairs Manager Keuro Life LLP

6.0 - 10.0 years

5 - 10 Lacs

Chennai

Work from Office

Role & responsibilities This is a full-time on-site role for a Regulatory Affairs Manager located in Chennai. The Regulatory Affairs Manager will be responsible for ensuring regulatory compliance, managing regulatory submissions, and overseeing the implementation and maintenance of quality systems. Day-to-day tasks include tracking regulatory requirements, preparing and submitting regulatory documents, and collaborating with cross-functional teams to ensure adherence to regulatory standards. Experience in Technology Transfers will be an added advantage. Preferred candidate profile Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs skills Experience with Regulatory Submiss...

Posted 5 months ago

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