Обязанности:
Regulatory affairs specialist In-Vitro Diagnostic Become part of one of the fastest growing Medical Devices companies globally. We continue to grow in Russian market and invest a lot in registration process, that's why we are excited to offer you opportunity to join our growing Regulatory Affairs team. We ready to see onboard a result-oriented and pro-active regulatory affairs professional, with proven in-depth knowledge of IVD medical devices registration. You will be responsible for a significant part of our business and you will be able to see the impact your work has on the improvement of our healthcare system. Responsibilities: Managing full cycle of IVD medical devices registration - preparation, submitting and registration dossier for the registration on the market of Russia in accordance with local legislation and standards Interaction with HQ RA regarding collecting registration dossiers and getting information required for registration – regulatory, technical and operational documentation Verification of the received regulatory, technical and operational documentation, local test reports regarding compliance with the requirements of Russian legislation. Communication with registration agencies & internal stakeholders Communication with government institutes & appropriate regulatory authorities Supervision of technical and clinical testing, checking laboratories for accreditation/license, evaluating the correctness of test reports. Control of actuality of data specified in registration certificates and dossiers. Making changes, if necessary. Keeping up to date with legislative and data updates from the manufacturer and authorized representative. Actively participate in teamwork, creating procedures and optimizing interactions with HQ. Maintain electronic archives of certificates and dossiers Information support in terms of registration issues to marketing, sales and other departments Requirements: Higher education, 3+ years experience in Regulatory Affairs in Medical Devices (manufacturing company or agency) Good command of English (upper - intermediate) Experience in running turnkey IVD registration projects. Including document preparation, testing, dossier preparation and submitting. Good knowledge and understanding of local legislation in regulatory sphere Result-oriented, pro-active team player, able to work independently, motivated to grow within the company Ability to learn lots of new information Great analytical and communication skills Conditions: Competitive compensation package including yearly KPI bonus (will be discussed individually during interviews) Corporate mobile and equipment support Social benefits (Health and Life insurance) Full-time job (5/2). We're working 100% in the office. Office located near m. Prospekt MiraПохожие вакансии
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