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Perform retrospective reviews of historical complaint records and complaint investigations.Assess complaint files for accuracy, completeness, and compliance with established protocols.Identify and elevate Potential Adverse Events and other compliance concerns.Support FDA CAPA activities, post-market surveillance, and remediation initiatives.Collaborate with Quality, Regulatory, Clinical, and Engineering teams to ensure regulatory compliance.Document findings, identify gaps, and support process improvement activities.Required Skills:10+ years of experience in complaint handling, complaint investigations, or post-market quality within the medical device industry.Strong knowledge of FDA regulations, CAPA, quality systems, and complaint management processes.Experience with retrospective reviews, remediation projects, and complaint documentation.Excellent analytical, documentation, and communication skills.Experience working in cross-functional quality and regulatory environments.Preferred Skills:Experience with FDA inspection remediation activities.Knowledge of Potential Adverse Event assessments.Familiarity with Post Market Surveillance processes. .