Registration Manager, Medical Devices

What to do:

• Ensure timely registration and certification/declaration (if necessary) for medical devices within Russian / Eurasian Economic Union (EAEU) legislations.
• Maintenance of current registration
• Dossier preparation as per Russian and EAEU requirements;
• Effective cross-functional collaboration to successfully achieve company goals
• Close collaboration with manufacturers (include working with manufacturers’ databases, share points or other manufacturers’ sources) to support dossiers preparation; and 3rd parties (such as Health Authorities, Consultancy, Laboratories, Translation agencies, etc.);
• Maintain and update RA Database: enter new documents and notification of all concerned parties (upon appropriate mailing list); Certificates tracking and update in time according to business needs;
• Monitoring of changes in the regulatory legislation of Russia and the EAEU countries.
• Providing reports on the work done on regular base.

• Completed higher education (chemical, biotechnological, biological, medical and pharmaceutical specializations);
• Work experience of at least 2-3 year in a similar position (background in an international pharmaceutical company is an advantage);
• Confident command of English (oral and written) – Upper-Intermediate;
• Deep knowledge of the regulatory system and legislation of Russia/ EAEU (EU is a advantage);
• Skills of effective workflow organization and self-discipline;
• Result-oriented, initiative, proactive
• The ability to conduct several projects at the same time;
• Ability to work with a large array of information.

• Hybrid type of work (3/2)
• Career opportunities
• Healthy work environment
• Flexiable benefits
• Annual bonus, meal allowance and voluntary medical insurance