Device Safety Officer

Role: Device Safety Officer (DSO) responsible for medical safety excellence at the intersection of pharmaceuticals and medical devices. Core responsibilities include conducting evidence-based device risk assessments, documenting and defending risk decisions, representing Medical Safety in cross-functional Risk Management Teams, reviewing and approving risk assessments, and leading standardization initiatives like global harms list development. The DSO ensures compliance with global device regulations such as EU MDR/IVDR, FDA 21 CFR Part 4, and ISO standards, and serves as a subject matter expert for audits and internal consultations. Qualifications: MD, MBBS, DO, or equivalent with at least 3 years postgraduate training and 2 years clinical practice experience; 2+ years in risk management for medical devices; active medical license and board certification preferred. Skills: strong ability to drive cross-disciplinary teams, rapidly assimilate new regulatory information, leverage AI tools, and communicate complex safety topics effectively. High-value specifics include experience with integral and non-integral medical devices, diagnostics, and software-as-a-medical device, with a focus on risk assessment and compliance in a pharmaceutical-led portfolio. Collaboration occurs within Global Medical Safety and cross-functional RMTs. Location: multiple US sites; role may involve remote work. The position offers an annual salary range of $199,000–$343,850 with comprehensive benefits.