Regulatory affairs specialist (In Vitro)

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 requirements