Regulatory Manager

7 days ago

Vijayawada, India Nulife Full time

- Maintain regulatory files and update regulatory authorizations, such as euMDR, 510(k), UCKA PPE & medical device licenses. etc. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes, and Support approval in other regions as required. - Ensure the Quality Management System complies with the Drugs and Cosmetics Act, Medical Device Rule 2017 & Medical Device Regulations, and is effectively established, maintained, and efficient. - Manage internal and external audits, inspection readiness, and Regulatory Authority inspections. - Ensuring personal and company compliance with local regulations, policies, and procedures. - Managing the complete PMS (post-market surveillance) process. - Managed product and process risk management, clinical evaluation, product verification, and validation. - Provide training to concerned employees related to ISO, MDR, GMP, PPE and Medical device regulations as per EU and assessment. - Assess device-related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities on time. Handle recalls and field actions, if required. - Review and approve translations of product labelling (e.g., labels, IFU, user manual) and promotional material (external and internal communication). - Understand local labelling requirements and ensure all activities related to product labelling are performed correctly. - Ensure compliance with Environmental regulations. Skills & Knowledge Educational Qualifications - B. Pharmacy/M. Pharmacy/B.Sc. /M.Sc. - Audit management euMDR, ISO13485 and 510K. Relevant (functional/Level) and total years of experience - Minimum 10 years of related experience

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