Collaborate with Regulatory, Quality, and Clinical Affairs to ensure traceability and compliance of all diagnostic-related datasets - The role is accountable for how CP work is delivered at scale, including people leadership, delivery standards, data and workflow quality, and regulatory readiness. * Ensure images, metadata, and annotations produced by teams are suitable for downstream AI/ML development, validation, and regulatory use * Ensure data practices meet regulatory, quality, and diagnostic development expectations, in collaboration with Quality Management and cross-functional teams, * Ensure teams are prepared for inspections and regulatory submissions (e.g. FDA, IVDR) through consistent execution practices and documentation, and that CP delivery outputs are reproducible, traceable, and defensible for scientific review and regulatory scrutiny - Diagnostics & Regulatory Readiness Data Strategy
mehr