Обязанности:
Key responsibilities: Maintaining a full cycle of IVD medical devices’ registration, including preparation, submission and maintenance of registration dossiers for approval in Russia, in accordance with local laws and standards Communicating with HQ Regulatory Affairs to collect registration documents and obtain the necessary regulatory, technical, and operational information for registration Reviewing the received regulatory, technical, and operational documentation, as well as local test reports, to ensure compliance with Russian legislation requirements. Interacting with internal stakeholders, registration agencies, government bodies, and relevant regulatory authorities Overseeing technical and clinical testing, verification of proper laboratory accreditation and licensing, and evaluation of the accuracy of test reports Monitoring the accuracy of data in registration certificates and dossiers, and making updates if necessary. Staying informed about legislative changes and updates from the manufacturer and authorized representative Active participating in teamwork, creating procedures and optimizing interactions with HQ Developing procedures and streamlining collaboration with HQ Maintaining electronic records of certificates and documents Providing informational support on registration-related matters to marketing, sales and other departments Requirements: Higher education 3+ years of experience in regulatory affairs for medical devices English – Upper-intermediate level Experience in managing end-to-end IVD registration projects, including document preparation, testing, dossier assembly, and submission Comprehensive knowledge and understanding of local regulatory requirementsПохожие вакансии
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