Device Safety Officer

• Evidence-based decision making for the severity of harms as a result of device-associated hazardous situations and associated probabilities of harm.
• Documenting, explaining, and defending device risk assessment decisions made, and updating Product Risk Management (PRM) deliverables based on new evidence and inputs from cross-functional peers and stakeholders.
• Representing Global Medical Safety at RMTs and quality event meetings convened for device assets.
• Review and sign off on device Product Risk Assessments (PRA) and other PRM deliverables requiring medical input.
• Leading standardization initiatives, including the development and maintenance of a global harms list.
• Ensuring a complete and comprehensive knowledge base of in-scope device assets and programs across the portfolio and product lifecycle, including but not limited to integral and non-integral medical devices, in vitro diagnostics, and software-as-a-medical device.
• Ensuring successful and compliant resolution of competing priorities and objectives across multiple stakeholders and programs.
• Meeting performance and risk metrics for device workflows that support strategic decision-making.
• Supporting special projects and initiatives as needed.

• Physician / Surgeon (MD, MBBS, DO, or equivalent), with at least 3 years of postgraduate training and 2 years of clinical practice experience is required.
• At least 2 years of experience in the application of risk management to medical devices is required.
• An active medical license and board certification in a relevant discipline is strongly preferred.
• Ability to effectively drive cross-disciplinary, highly matrixed teams to meet safety and compliance objectives for device assets is required.
• Ability to rapidly assimilate and apply new information for device assets and regulations is required.
• Demonstrated ability to leverage AI-enabled tools and technologies to improve decision-making, streamline work processes, and enhance business outcomes.
• Ability to clearly and concisely summarize complex device safety topics in writing and in presentations for audiences of diverse professional backgrounds is required.
• Strong written and verbal communication skills are required.
• Strong Microsoft Office Suite skills (Word, Excel, PowerPoint) are required.

Demonstrates expertise in medical device risk management, including the ability to conduct thorough product risk assessments and effectively communicate complex safety topics. Leverages AI-enabled tools to enhance decision-making and streamline processes while ensuring compliance across diverse stakeholders.

• Medical Device Risk Management
• Product Risk Assessment
• Cross-Disciplinary Team Leadership
• Strong Written and Verbal Communication
• AI-Enabled Tools Utilization

• Risk Management
• Clinical Practice
• Device Safety Assessment
• Regulatory Compliance
• Data Analysis

• Effective Communication
• Team Collaboration
• Problem Solving

• Medical License
• Board Certification

• Medical Devices
• Product Risk Management
• In Vitro Diagnostics
• Software-as-a-Medical Device
• Global Medical Safety

• Microsoft Office Suite
• AI-Enabled Tools