Position Overview

Responsible for the execution of product complaint handling for Class II/III neurovascular medical devices. Under minimal supervision, ensure complaint handling tasks are completed accurately and in a timely manner while maintaining compliance to internal standards/procedures and applicable external industry regulations. Work closely with FA management to help drive continuous improvement activities, and provide support to distributors, manufacturing facilities, and MicroVention Europe customer service. Job duties:
  • Receive, review, analyze, and process product complaints from domestic and international customers. Investigate complaints by gathering sufficient information from customers, field representatives, clinical staff, and other internal resources for complete understanding of the event.
  • Perform required follow up activities to ascertain additional information.
  • Document all information related to the investigation of reported complaints in the complaint handling database.
  • Determine complaint codes and patient outcome codes.
  • Actively monitor complaints through the complaint process lifecycle to ensure the complaint files are processed in a timely manner, per the established goals.
  • Construct clearly written and grammatically sound customer response letters, as required.
  • Review completed complaint files that are ready for closure for consistency and accuracy. Ensure complaint information, investigation activities, escalation to management (as appropriate), follow up activities, complaint codes, complaint adverse event reporting decision trees and customer letters are accurate and complete.
  • Identify and address any discrepancies in the product investigation root cause/conclusions and collaborate with returns goods lab or engineering staff for potential revisions, as needed.
  • Participate in various continuous improvement projects that lead to the development of robust complaint handling processes.
  • Assist and support management during preparation for, and during, company audits.
  • Assist in the development and updates to the associated department procedures and work instructions.
  • Assist in the development, planning and delivery of training material to Field Assurance staff and other functional teams within the organization for the complaint handling process.
  • Provide guidance and training as needed to Field Assurance Analysts.
  1. Perform additional responsibilities as assigned.

    1. Bachelor’s degree or equivalent combination of relevant experience, education and training.
    2. Minimum of five (5) years complaint handling/post-market surveillance experience with Class II/III vascular intervention, surgical/implantable, or neurological interventional medical devices.
    3. Knowledge of FDA 21 CFR part 803/820, ISO 13485:2016, Vigilance (MEDDEV), and Canadian adverse event reporting regulations for Class II/III medical devices.
    4. Strong analytical and critical thinking skills with the ability to make sound judgments based on objective data and acquired knowledge.
    5. Excellent writing/composition skills with the ability to construct clear and comprehensive clinical/technical narratives.
    6. Excellent verbal communication skills, with demonstrated success in establishing and maintaining effective interpersonal relationships.
    7. Excellent time management skills with the proven ability to prioritize daily conflicting demands to meet strict regulatory compliance and organizational deadlines.
    8. Excellent cross-functional team collaborative skills.
    Desired Qualifications
    1. Experience working in a clinical/healthcare setting (endovascular, cardiovascular, critical/surgical care) or related medical device environment.
    2. Experience with preparing and submitting MDRs/eMDRs for Class II/III devices.