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: Strong leadership, communication, and project management skills are essential. The ability to interpret complex regulations and adapt to different documentation requirements is also critical.
Please note that applicants for this position should be from the following locations: Patan, Unjha, and Mehsana.
Pay: ₹1,200,000.00 - ₹1,500,000.00 per year
Work Location: In person
