Regulatory Affairs Specialist MedTech

Main Responsibilities:

• Perform registration and certification/declaration processes for medical devices.
• Documents request from manufactures include working with manufacturers’ databases, share points or other manufacturers’ sources
• Registration dossier preparation
• Ensure timely registration of all new products and obtaining of relevant licenses
• Review product registrations for accuracy and completeness of documentation
• Cooperation with outsourcing companies
• Responsible for accurate documentation of new products for submissions to authorities
• Local RA and QA Audits attendance
• Maintain and update RD Database: enter new documents to DB and notification of all concerned parties (upon appropriate mailing list)
• Certificates tracking and update in time according business needs
• Dossiers archiving
• Approve: SAP codes, IFU, Advertising materials
• Develop relationships: participation in conferences and seminars organized by state authorities involving in registration process

Requirements:

• Higher education (Biomedical engineering education is a must / background is an advantage)
• 3 + of experience in Regulatory Affairs in Medical Devices is a must
• Knowledge of English language upper-intermediate (sufficient for business communication purposes)
• Knowledge of the regulatory framework governing the procedures for state registration, certification and declaration of conformity of medical devices on the territory of the Russian Federation and the EAEU countries is a must
• 2+ years of experience in organizing technical tests, toxicological studies and clinical trials of medical devices for the purpose of their registration in the Russian Federation and the EAEU countries is a must
• Result-oriented, initiative, proactive
• Team player
• Good communication skills (collaborative approach), open-minded