Experteer OverviewIn 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 / BenefitsManage technical requests during submissions and regulatory transitionsOversee initiatives for launched and registering products across multiple countries and changesEnsure compliance with GOPs/SOPs and quality standardsMaintain up-to-date expertise on regulatory requirements for IVDs across regionsPlan and execute IVD validation activities and related technical documentation (e.g., Performance Evaluation, IFU updates)Provide technical guidance to Product Development for post-launch strategiesConduct and supervise scientific literature reviewsLead a dedicated team with clear planning, task allocation, and alignment to timelines and regulatory needsCoordinate with Regulatory Affairs during submission processesResponsabilitàMaster's degree in a scientific/biomedical fieldMinimum of two years of experience in IVD validationUnderstanding of mandatory regulatory requirements for IVD medical devicesStrong planning, problem-solving, and cross-functional interaction skillsFluent in Italian and English
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