Senior Medical Device Registrar

Job Overview

We are seeking a skilled Regulatory Compliance Professional to join our team. This role will be responsible for ensuring timely and high-quality registration of medical devices in the Russian Federation, as well as in the CIS and Central Asia countries, in compliance with applicable national and international regulatory requirements.

• Registration of new products, including direct preparation of dossier documents, process support at all stages, coordination of documentation with both internal customers (including manufacturers' representatives) and external partners in the Russian Federation, a number of CIS and Central Asian countries.
• Amending registration dossiers and certificates.
• Evaluating and processing notifications of changes in products from manufacturers; determining a strategy for further actions to make changes, if necessary.
• Maintaining product compliance with current regulatory requirements.
• Obtaining permits, including metrological certificates, and obtaining licenses.
• Monitoring and analyzing changes in the regulatory framework of the Russian Federation, the EAEU, a number of CIS and Central Asian countries.
• Monitoring the safety of medical devices and interaction with regulatory authorities.
• Participation in the work of specialized associations and external working groups.
• Archiving and maintaining registration documentation (paper and electronic).
• Providing administrative support to the regulatory department (organizing translations and notarizations, ordering couriers, working with electronic document management, including 1C).
• Interaction with other departments when preparing responses, requests, justifications to external organizations.