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Company Description: LanceSoft - Pharmaceutical ClientJob DescriptionOVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts.
DUTIES: Responsible and accountable for on-time submission and accuracy of regulatory reportsReview and complete determination associated Medical Device Report and/or Vigilance ReportKnowledge of and familiarity with global regulations for reportingDirectly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse eventsInteract positively with internal, external business partners and colleaguesAdhere and comply to work instructions, standard operating procedures, and regulationsExpedite investigations by collaborating with internal/external business partnersAchieve productivity targetsFully trained within three months of hireAchieve accuracy targets for complaint documentationsParticipate in projects and eventsComplaint determinationReportability assessmentsConduct follow-ups with complainant, reportersChecking your own workUpdating SharePointTracking complaints in the process for closureAll other duties as assignedQualificationsBachelor's Degree or equivalent experienceGenerally requires 2-4 years of related work experienceRAC or ASQ certifications a plusAdditional InformationAll your information will be kept confidential according to EEO guidelines. SummaryType: ContractFunction: Supply ChainExperience level: Mid-Senior LevelIndustry: Pharmaceuticals

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