DUTIES AND RESPONSIBILITIES

· Maintain regulatory files. Maintain 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, 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 labeling (e.g., labels, IFU, user manual) and promotional material (external and internal communication).

· Understand local labeling requirements and ensure all activities related to product labeling are performed correctly.

Qualifications and skills

Experience: Several years of experience in regulatory affairs, quality assurance, or a related field within the medical device industry is usually necessary. Experience with specific global markets (e.g., EU, US) is often a requirement.

Skills: Solid leadership, communication, and project management skills are essential. The ability to interpret complex regulations and adapt to different documentation requirements is also critical.

Pay: ₹35,000.00 - ₹40,000.00 per month

Work Location: In person

📌 Regulatory Affairs Officer (Patan)
🏢 MRK Healthcare
📍 Patan