Pubblicato il 17 giugno
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Experteer Overview Per essere preso/a in considerazione per un colloquio, la preghiamo di assicurarsi che la sua candidatura sia pienamente in linea con le specifiche del lavoro riportate di seguito. In this role you drive technical initiatives for existing and registering products across countries, guiding regulatory interactions and validation activities. You lead a small team within Product Development Immuno to ensure compliant, timely scientific work, from validation to post-launch support. You will shape technical documentation and stay ahead of evolving regulatory expectations for IVDs. This is a chance to impact global healthcare solutions through rigorous scientific leadership and cross-functional collaboration. Retribuzione / Benefits Manage technical requests during submissions and regulatory transitions Oversee initiatives for launched and registering products across multiple countries and changes Ensure compliance with GOPs/SOPs and quality standards Maintain up-to-date expertise on regulatory requirements for IVDs across regions Plan and execute IVD validation activities and related technical documentation (e.g., Performance Evaluation, IFU updates) Provide technical guidance to Product Development for post-launch strategies Conduct and supervise scientific literature reviews Lead a dedicated team with clear planning, task allocation, and alignment to timelines and regulatory xrdztoy needs Coordinate with Regulatory Affairs during submission processes Responsabilità Master's degree in a scientific/biomedical field Minimum of two years of experience in IVD validation Understanding of mandatory regulatory requirements for IVD medical devices Strong planning, problem-solving, and cross-functional interaction skills Fluent in Italian and English #J-18808-Ljbffr
