Обязанности:
An international company has opened a competition for the position of Regulatory Affairs SpecialistResponsibilities:Managing full cycle of medical devices registration - preparation, filing and registration dossier for the registration on the market of Russia in accordance with country’s legislation and standards;Interaction with HQ RA regarding collecting registration dossiers and getting information required for certification – regulatory, technical and operational documentation;Verification of the received regulatory, technical and operational documentation regarding compliance with the requirements of Russian legislation;Communication with certification agencies & internal stakeholders;Communication with government institutes & appropriate regulatory bodies;Control of existing certificates & the expiration dates;Maintain electronic archives of certificates and dossiers;Information support in terms of registration issues to marketing, sales and other departments.Requirements:Higher education, 2+ years experience in Regulatory Affairs in Medical Devices (producer company or agency);Good command of English – intermediate;Good knowledge and understanding of local legislation in regulatory sphere;Ability to learn lots of new information;Great analytical and communication skills.Benefits:Fixed salary (based on interview results);Annual bonus;Transport compensation;Competitive salary and bonus system;Medical and life insurance.Похожие вакансии