Regulatory affairs specialist (MD invivo)

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.