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08/12 Nirmala Singh
Assistant Manager - HR at Medico Electrodes International Ltd

Views:155 Applications:6 Rec. Actions:Recruiter Actions:4

Medico Electrodes - Quality Assurance Role (3-6 yrs)

Noida Job Code: 30005

Job Description :

- Timely compile Product Technical Files/ QA records required for renewals, updates and registrations.

- Update and maintain UDI (GTIN) barcode log sheet and registration certificates log sheet - client wise.

- Maintain regulatory files /database and chronologies in good order.

- Review art designs and labels for compliance with regulatory and customer requirements.

- Review changes to existing products and processes to define the requirements for regulatory submissions.

- Routinely review changes in the regulatory framework such as USFDA, EU, ROW, CIS, India etc. and product standards, update the list of product standards in a timely manner, wherever applicable.

- Represent Regulatory Affairs on product development project teams to ensure all regulatory requirements are met throughout the development process.

- Complete submissions to all countries wherever products are expected to be launched / placed in the market.

- Keeping self, regularly updated through subscriptions and relevant online forum updates.

- Actively pitch-in daily QA department affairs, participate and contribute in inter-departmental requests.

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