Vigilance Reporting Specialist
Core
Lead complex post-market complaint and adverse-event investigations from intake through closure, ensuring regulatory compliance and accurate records.
Role type
Senior IC vigilance reporting specialist
Builds
Post-market surveillance reports, root cause analysis documentation, and customer/regulatory response letters
Domain
Medical devices / Quality Assurance / Regulatory Compliance
Required skills
Post-market surveillance, QMS, regulatory requirements, technical documentation, data analysis, root cause analysis, CAPA methodologies
Preferred skills
Medical-device vigilance reporting experience
Responsibilities
Lead complex complaint and adverse-event investigations including good-faith follow-up, product or service analysis review, and root cause analysis; Analyze complaint data to identify trends, defects, safety concerns, and potential product improvements; Ensure accurate complaint coding and records; Prepare and review customer response letters and internal responses; Support the training and qualification of new investigators on complaint handling processes
Seniority
Mid-level, hands-on IC