End-to-End Lifecycle Quality: Provide quality leadership across assay development, validation, design transfer, commercialization, and lifecycle management, ensuring compliance with design controls and maintaining traceability from intended use and user needs through verification, validation, risk management, clinical evidence, and labeling. IVD Regulatory Compliance: Provide strategic quality leadership across IVD development, evidence generation, labeling, regulatory strategy, and lifecycle management, ensuring compliance with FDA and international regulatory requirements, including EU IVDR, ISO 18113, and 21 CFR Part 809.