Device Safety Officer

Role: Device Safety Officer (DSO) ensuring medical safety excellence at the intersection of pharmaceuticals and medical devices within Johnson & Johnson's Innovative Medicine portfolio. Responsibilities: lead medical risk assessments across device design, development, and post-market phases; serve as the primary Medical Safety point in cross-functional Risk Management Teams; ensure compliance with global regulations such as EU MDR, FDA 21 CFR Part 4, and ISO standards; review and approve Device Risk Assessments; develop and maintain global harms lists; and represent safety in audits and inspections. Qualifications: MD, MBBS, DO, or equivalent with a minimum of 3 years postgraduate training and 2 years clinical practice; at least 2 years in medical device risk management; active medical license and board certification preferred; strong ability to lead matrixed teams, quickly assimilate new information, and leverage AI tools; excellent communication skills; proficiency in Microsoft Office. High-Value: focus on medical devices, in vitro diagnostics, and software as a medical device, across design, regulatory, and post-market lifecycle, with emphasis on risk management, safety assessments, and compliance. Work Setup: locations in Horsham, PA; Raritan and Titusville, NJ, with flexibility for cross-site collaboration.