RA&QA Director \Healthcare

| * Ensuring legal regulation and quality in the markets of medical equipment and pharmaceuticals in Russia and the CIS countries. • Supporting businesses by obtaining appropriate regulatory approvals and monitoring compliance with Russian legislation and company standards. * Maintaining the company's quality Program in compliance with all legal standards. * Support for the internal audit program, conducting production audits in accordance with ISO 13485, warehouse audits in accordance with GWP, and annual due diligence of suppliers. * Checking the correctness, functionality and effectiveness of all quality processes and procedures. * Assessment / audit of current and newly developed procedures and systems for compliance with legislation. * Control of external audits by regulatory authorities, quality audits by an ISO-certified body, clients, etc. * Monitoring of CAPA and the complaint processing system in Russia and the CIS. * Organization of the work of the geographically distributed team of the division. Key result: • building effective work of the regulatory relations division taking into account changes in legislation, forming a professional team; • re-registration of the entire product portfolio (more than 15,000 articles, 100 registration certificates); * registration of 8 new products; • obtaining a Russian GMP certificate; • implementation of the Pharma Track and Trace project); * strict adherence to project budget and time frames.