Job Details

ID #20227600
State California
City Irvine
Job type Contract
Salary USD Depends on Experience Depends on Experience
Source NetSource, Inc.
Showed 2021-09-25
Date 2021-09-24
Deadline 2021-11-22
Category Et cetera
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GMP Customer Complaints Analyst

California, Irvine, 92602 Irvine USA

Vacancy expired!

Please note that this is a 12 month contract position.The purpose of the position is to review and process product complaints received through various communication modalities and contribute to complaint management system in accordance with internal and external complaint handling procedures while demonstrating world-class customer support. Focus areas are Regulatory Reporting to FDA under 21 CFR, Part 803, Vigilance reporting per Regulation (EU) 2017/745 and MED DEV 2.12-1, Device Specific Vigilance Guidance, other relevant regulations as appropriate and management of Health Authority Requests.Duties & Responsibilities may vary depending on the Operating Company the individual is assigned to.Duties and ResponsibilitiesUnder limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines, this position will:Demonstrate world class customer support and maintain knowledge of relevant Operating Company’s products and servicesAssess, process, and close complaint files within scope of internally and externally manufactured products in accordance with associated complaint handling procedures and CQ expectations. This may include assigning product experience and patient codes. Utilize MD Workflow reports to identify tasks and manage common Email inboxesMake regulatory reporting determinations on applicable files for one or more Business Units. Execute file reviews, making and/or reassessing MDR and/or MDV decisions and managing relevant complaint files activities.File Medwatch report forms within required timelines as applicableFile MDVs in accordance to EEA, Switzerland and Turkey, candidate countries and other third countries guidelines within the required timelines as applicableCreate and/or forward additional information follow up questions as part of complaint investigation. Assign the appropriate complaint system activities to other sites to ensure timely execution of complaint investigation and complaint file managementAppropriately utilize risk management documentation to support the complaint’s regulatory reporting processInvolved in the maintenance of the Reportable Malfunction List and regulatory reporting tables in support of complaint management database activities as applicableManage Standard Health Authority Requests of Health Authorities incl. justifications for non-reporting in accordance with FDA and EU regulations as applicableSupporting regulatory additional information requests and actively supporting compliance auditsParticipate in audit and compliance review processes as neededMaintain a full understanding of current Customer Quality and other independent quality system policies and proceduresParticipate in assigned projects towards desired business outcomesParticipate in the onboarding training of new associates and/or existing associates learning a new productParticipate in escalation process as requiredPartnering and influencing with stakeholders both internally and externally to drive needed change and/or execution of complaint related mattersBe responsible for communicating business related issues or opportunities to next management levelBe responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and proceduresPerform other duties assigned as neededExperience and EducationCompleted apprenticeship or Baccalaureate degree, preferably Scientific, Medical, Life Science, Health Science, Technical, or Engineering field or University/Bachelor’s Degree or equivalent experience2-4 Years related experience is desirable (A combination of experience and education can be allowed)Knowledge of applicable quality, FDA (Food & Drug Administration); Medical Device Directives/ Regulation & ISO (International Organization for Standardization) requirementsKnowledge of human anatomy, medical terminology and products of applicable Business UnitsRequired knowledge, skills, abilities, certification/licensesSkills SetStrong written and verbal communication skills. Fluent spoken/written English required.Strong decision-making skills – able to make sound business decisions with sometimes limited informationAbility to work in a cross-functional and matrix environmentAbility to work independentlyContinuous Improvement focusTime management.Ability to handle multiple priorities/ sudden changes in prioritiesAbility to work in stressful/fast paced environmentAbility to work and interact with co-workers to accomplish company goals in a team environmentAnalytical/Problem Solving SkillsAbility to learnStrong attention to detailComputer Skills:PC computer skills, MS Windows, MS Office (MS Outlook, Word, Excel, PowerPoint) and other communication tools such as Microsoft Teams, Skype, Zoom etc. Applicants must provide their phone number. Job reference number A1004.

Vacancy expired!

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