Job DescriptionThe Regulatory Post Market Surveillance Analyst captured complaints, investigates customer complaints, makes initial reporting decisions, files regulatory reports, and ensures completeness and consistency of complaint documentation.
This position reports to a local Regulatory Post Market Surveillance Supervisor or Manager with dotted line to the European Regulatory Post Market Surveillance Supervisor or Manager.Essential Job DutiesThis position has responsibility and authority for:Investigating complaints daily:European Region Complaint intake and triage for reportabilityPerform the preliminary classification of complaints and escalate complaints that require additional review.Perform Failure Analysis investigation review and escalate complaints that require additional review.File EU Manufacturer Incident Report (MIR) Reports as applicableEscalate Adverse Event/Serious incidents or Incident reports to Adverse Analysts as identifiedEvaluate documentation for completeness and consistency, and assign additional actions as necessary to close the complaint file.As applicable, approve final complaint file for closure after all applicable actions are completed.Manage complaint workload to required backlog goals.Review and analyze lot documentation (DHRs) to determine if there are any anomalies that maybe related to reported product failures.Escalate complaints to the Regulatory Post Market Surveillance Supervisor/Manager when new failure modes are encountered.Escalate complaints with potential related product failures to the Post Market Investigation (PMI) groupEvaluate complaints for reporting requirements in accordance with company procedures and Regulatory requirementsInterface with Customer Service and hospitals to gather additional information required for complaint investigation, including retrieval of RMACreate customer response letters upon requestProvide peer review and feedback of complaints and reportsParticipate in new hire training and continuous Regulatory Compliance training as requiredParticipate in process improvement activities to continuously improve process effectiveness#J-18808-Ljbffr