Product Safety & Vigilance Specialist

Job description

Make an impact on patient safety. We are seeking a Product Safety & Vigilance Specialist to help identify, assess, and mitigate real and potential product safety risks across our medical device portfolio. In this role, you will serve as a subject matter expert in complaint management and medical device reporting, partnering closely with global teams, regulatory authorities, and internal stakeholders to ensure compliance, continuous improvement, and patient protection. What You’ll Do: - Lead investigation and assessment of potentially reportable product safety events (MDRs) and complaints - Collect, analyze, and document product surveillance data to identify trends, risks, and opportunities for corrective action - Review product complaints related to quality, safety, and performance; conduct interviews and device history reviews as needed - Coordinate cross‑functional activities including failure analysis, CAPA, nonconformance, and root cause investigations - Develop and implement proactive risk minimization and benefit–risk assessment plans - Ensure complete, accurate, and timely documentation through investigation closure - Support Field Safety Corrective Actions (FSCA) and multi-...