Обязанности:
Responsibilities: Overseeing the complete process of registering medical devices - including preparation, compilation, and submission of registration dossiers for marketing authorization in Russia, while ensuring compliance with local laws and standards. Collaborating with Headquarters Regulatory Affairs to gather necessary documentation and details for certification, including regulatory, technical, and operational data. Scrutinizing regulatory, technical, and operational documents to confirm alignment with Russian legal requirements. Coordinating with certification bodies, internal stakeholders, government entities, and regulatory agencies for successful registration. Monitoring validity periods of current certificates and managing certificate databases. Organizing electronic archives of certificates and dossiers for easy access. Providing guidance on registration-related matters to departments like marketing, sales, and other relevant teams.Похожие вакансии