Executive Director, CSRM Device and Product Quality

Job description

Job Description The Executive Director, CSRM Device and Product Quality provides strategic and operational leadership for a global Center of Excellence delivering medical and scientific expertise in device safety, health hazard oversight, and product quality medical risk assessment. Reporting to the Vice President, Clinical Safety and Risk Management (CSRM), this role sets clinical risk management strategy, governance, and compliant processes for medical support of devices and combination products across the full product lifecycle. The role is accountable for leading the strategy and implementation of timely medical risk assessment in support of quality issues across developmental and commercial products. The Executive Director leads cross‑functional collaboration across CSRM Therapeutic Area leadership, device development, commercial, manufacturing, and regulatory organizations to ensure patient safety, regulatory compliance, and successful execution of the Company’s product portfolio. Key Responsibilities: Device Safety Strategy and Governance Define and own the global safety strategy for interpretation of regulatory requirements related to medical safety contributions to drug de...