Device Safety Officer

Role: Device Safety Officer (DSO) ensures medical safety excellence at the intersection of pharmaceuticals and medical devices within Johnson & Johnson's Innovative Medicine portfolio. Responsibilities: lead device risk management activities across design, development, and post-market stages; serve as the primary medical point of accountability for device asset risk assessments; represent Global Medical Safety in cross-functional Risk Management Teams; review and approve risk assessments and PRM deliverables; develop global harms lists and standardization initiatives; maintain comprehensive knowledge of device assets including medical devices, diagnostics, and software; support audits and inspections; and contribute to process improvements. Requirements: MD, MBBS, DO, or equivalent with at least 3 years postgraduate training, 2+ years clinical practice, and 2+ years in medical device risk management; active medical license and board certification preferred; strong cross-disciplinary team leadership, rapid learning ability regarding device regulations, and effective communication skills. Preferred skills include clinical operations, compliance, risk management, and safety investigations. High-Value: focus on medical devices, diagnostics, software-as-a-medical device, risk assessment, global regulations (EU MDR/IVDR, FDA 21 CFR Part 4, ISO standards). Work Setup: multiple U.S. sites; specific travel requirements not detailed but likely demand for cross-functional collaboration.