Regulatory Manager

• 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