Assistant Manager - HR at Medico Electrodes International Ltd
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Medico Electrodes - Quality Assurance Role (3-6 yrs)
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.