Device Safety Officer

Johnson & Johnson seeks a Device Safety Officer to serve as the medical accountability lead for device risk management across the pharmaceutical-medical device portfolio. The role requires ensuring medical safety excellence throughout device design, development, and post-market lifecycle while maintaining compliance with global regulations.

Responsibilities

• Make evidence-based decisions on harm severity and probability for device-associated hazards
• Document and defend device risk assessments; update Product Risk Management deliverables
• Represent Global Medical Safety at Risk Management Team and quality event meetings
• Review and approve Product Risk Assessments and other risk management deliverables
• Lead standardization initiatives and maintain comprehensive knowledge of device portfolio

Requirements

• MD, MBBS, DO, or equivalent with 3+ years postgraduate training and 2+ years clinical practice
• 2+ years experience applying risk management principles to medical devices
• Active medical license and board certification in relevant discipline strongly preferred
• Ability to lead cross-functional matrixed teams on safety and compliance objectives
• Expertise in global device regulations including EU MDR/IVDR, FDA 21 CFR Part 4, ISO standards
• Demonstrated proficiency with AI-enabled tools and advanced Microsoft Office Suite skills
• Strong written and verbal communication abilities for diverse audiences

Compensation: $199,000 - $343,850 base