- Defining a localization strategy for medical equipment ; - Identification and justification of technical solutions within the assigned responsibility perimeter to achieve the company's goals in terms of quality, timing and cost; - Coordination of technological, regulatory and commercial functions on registration and localization of medical equipment; - Organization and leadership of work with suppliers within the framework of registration and localization of medical equipment as part of the working group; - Analysis and optimization of technical requirements for medical equipment; - Preparation of product registration, validation plans, organization of reverse engineering; - Organization and leadership of work on the implementation and maintenance of the QMS in accordance with GOST R 13485: 2017; - Ensuring the economic efficiency of projects on entrusted medical devices; - Managing the approval, approval and tracking of test plans; - Quality control of the technical documentation provided for and conclude contracts with new technology suppliers for localization. *Preparation and holding of investment committees. * Organization of product registration. * Organization of product testing in order to determine its suitability for localization. * Preparation and control over the execution of the department's budget. Key Results: * There are 12 active projects in operation with different stages of release ( include localization steps according to State Order No. 719). * Successful team of 3 employee created. * Issued 5 Registration Certificates. * Rostec State Corporation received the status of Technological Leader for winning 2 projects (research and development) in cardiology.

*Organization of work 3 sub-division: Development, Regulatory Affairs, R&D. 7 subordinates in Russia ( Sr. specialists, specialists and engineers). *Search for and conclude contracts with new technology suppliers for localization. *Preparation and holding of investment committees. * Organization of product registration. * Organization of product testing in order to determine its suitability for localization. * Preparation and control over the execution of the department's budget. Key Results: * There are 18 active projects in operation, 8 in the stage of market launch. * Successful team of 7 employee management and development.

*Organization work of geographically distributed team of the division: 10 subordinates in Russia and CIS (supervisor, Sr. specialists and specialists roles). * Ensuring legal regulation and quality in the markets of medical equipment and pharmaceuticals ( http://3M.https://www.3m.com/3M/en_US/health-care-us) in Russia and the CIS countries. - Supporting businesses by obtaining appropriate regulatory approvals and monitoring compliance with Russian and EAEU legislations and company standards. * Preparation and control over the execution of the department's budget. * Personal dossiers preparation for Company critical products according to Russian and EAEU legislation. * 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. Key results: -build efficiency networking with Authorities, Associations and RA KOLs - 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, 120 registration certificates); * registration of 20 new products; - EAEU pilots in MD are in good progress; - obtaining EAEU reg.certificates for drugs; - obtaining a Russian GMP certificate; - implementation of the Pharma Track and Trace project; * strict adherence to project budget and time frames; - Suссessful team of 10 Specialists management and development;

- Organization of obtaining of regulatory approvals for new and modified product lines. - Participating in projects to bring new products to market, advising the team on regulatory requirements and monitoring their strict compliance at all stages of development. * Building effective interaction with regulatory authorities, tracking regulatory trends, and monitoring changes in legislation. * Representation of the company at specialized events. * Maintaining the company's quality Program in compliance with all legal standards. - Support for the internal audit program. * 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. * Monitoring of CAPA and the complaint processing system in Russia and the CIS. * Organization of effective work of the Department's team (12 full-time employees and 6 freelance employees. Russia, Belarus, Kazakhstan, Uzbekistan). Key result: * organization of re-registration of the portfolio due to changes in legislation (60,000 articles); * creating an effective professional team of the Russian division "from scratch".

* Providing business support through obtaining appropriate regulatory approvals, compliance with the laws of Russia and CIS countries, and company guidelines. * Organizing the processing of complaints, feedback, and reporting on problematic situations. * Production audit in accordance with ISO13485. * Building effective interaction with regulatory authorities, tracking regulatory trends, and monitoring changes in legislation. Key result: * creating a team "from scratch"; * introduction of new products to the market with obtaining all permits during a difficult period of changing legislation.

* Development and preparation of the necessary documents for registration of the Registration Certificate of the Federal service for supervision of healthcare in risk classes I, 2A, 2B and 3 and certification of the company's medical products in accordance with the regulatory requirements of the Russian Federation. * Monitor changes in the legislation of Russia, CIS countries and foreign countries regarding compliance procedures. * Participation in the work of submitting complaints to suppliers and reviewing claims for product quality and their elimination. * Participation in internal audits. Organization of corrective actions in case of detection of non-compliance of products with the established requirements and in case of incorrect application of the conformity mark. * Interaction with foreign colleagues, business partners, and regulatory authorities. Key results: * systematization of the regulatory function in the company; * registration of 10 new products; - the process of implementing the quality system has started.

* Head of the Department for regulatory relations of Russia and the CIS Medtronic / Covidien (August 2008-may 2011). * Deputy head of the representative office of Dentsply Russia Limited (December 1997-August 2008).