The Regulatory Affairs (RA) Specialist will be responsible for the preparation of regulatory submissions required to market new or modified medical devices in Russian Federation. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business.
RA Specialist is to take care of services in regulations, registrations, technical files and standards and to assist in the complaint handling for devices related to a business unit.
The level of salary will be discussed individually;
Good career experience in international company;
Voluntary Medical and Accidental insurance;
Comfortable office in Moscow Business Center 'Moscow City'.
Preferably Bachelor's degree / University degree in sciences the preference medical / pharmaceutical oriented.
Ideal candidate will have the ability to understand and interpret the Russian and international medical device regulatory requirements.
Minimum 2-5 years’ experience in the medical devices industry in the RA department.
Current knowledge of the Russian medical device regulatory requirements, Good practice in Quality System Regulations (QSR), current knowledge of European Medical Device and European quality system standards.
Ability to effectively communicate in English both verbally and in writing to all levels within the organization and external to the organization.
Ability to organize work; project management experience desirable.
Quality audit experience is preferable
Knowledge of the Quality Standards ISO 9001 and ISO 13485 is advantage.
Полная занятость, полный рабочий день, у работодателя