Regulatory Affairs Specialist

An international company has opened a competition for the position of Regulatory Affairs Specialist

Responsibilities:

To be responsible for the quality of registration processes in the specified region: to prepare applications for registration, to create registration dossiers, to implement / monitor timely submission of documents to relevant authorities and organizations, respond promptly to received notifications and additional requests from public authorities;
To monitor the submission of registration dossiers and the expiration dates of registration certificates;
To inform the local business about the list of required samples for registration and monitor their receipt, as well as transfer to the appropriate authorities for testing;
To maintain systematic monitoring of state registration, changes in registration documents, and, if possible, facilitate the acceleration of this process;
To promptly request, monitor receipt and arrange the transfer of the necessary materials for registration;
To monitor and track the necessary payments for the implementation of registration / certification / declaration processes;
To archive and maintain in structured form documents in relation to all assigned and led registration processes (paper carriers, electronic archive);
To ensure the safety of all registration documents and documents submitted in the registration dossier;
To timely check, maintain and update all necessary databases of the Company regarding registration;
To maintain weekly communication with regional regulatory counterparts regarding active and planned registration projects in order to comply with project lead times;
To identify and inform the Company's employees of regional requirements for registration and product labeling;
Develop a local sticker layout for compliance with relevant regulatory requirements at the national (regional) level;
To assist the Head of the Registration Department in preparing reports on costs and statuses for registration projects;
To know the decisions, orders, orders, normative, methodical documents and manuals regarding registration and declaration in relation to the specified region;
To provide timely information to interested departments of the company on new registrations and changes to the registration documentation for medical devices;
To interact with the Head of the Registration Department, inform on a regular basis about the results of his activities and the difficulties encountered, timely inform the Head of the registration department regarding the lack of necessary documents for the registration process, as well as the failure to comply with the terms of the registration plan;
To travel on business trips to discuss projects on registration, collection of missing information, fulfillment of tasks within the framework of corrective measures, support of inspection trips to production and provision of exit tests for registration purposes;
To monitor the fulfillment by suppliers of registration and certification services of their obligations in terms of providing the necessary regulatory documentation and its quality, in a timely manner, inform the Head of the registration department of the failure of providers to meet the deadlines and quality of providing / preparing documents;
To be responsible for monitoring the safety of registered medical products of the Company;
To participate in the preparation of communication in the RZN regarding the monitoring of safety, the control of the treatment of medical devices, and participate in the preparation and implementation of a corrective action plan.

Requirements:

English language - upper-intermediate;
Good knowledge and understanding of local legislation in regulatory sphere;
Experience of working in Regulatory Affairs - at least 2 years.

Benefits:

Fixed salary (based on interview results);
Medical and life insurance;
Annual bonus;
Mobile Compensation.

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