Position Overview

Responsible for the execution of product complaint handling for Class II/III neurovascular medical devices. Provide guidance and direction to Analyst staff regarding complaint interpretation, complaint investigation activities, and appropriate complaint file documentation. Perform high-level complaint handling activities and projects associated with post-market surveillance and quality improvements. Job duties:
  • Receive, review, analyze, and process complex and critical complaints.
  • Provide guidance to complaint handling team regarding interpretation of complaints, complaint coding, and regulatory reporting assessments.
  • Monitor the daily movement of open complaint activity utilizing the Field Assurance Workflow Tracker and other internally established workflow spreadsheets.
  • Audit/approve complaint files for consistent and timely closure, ensuring accuracy and completion of complaint information and investigation activities, as well as thorough documentation of complaint investigation activity. Drive timely closure of investigation records and complaint files through communication with Field Assurance (FA) team members and other internal partners as needed.
  • Identify discrepancies in product investigation root cause/conclusions and collaborate with RG Lab or engineering staff for potential revisions, as needed, for inclusion in regulatory reports and customer responses.
  • Assess adverse event reports related to global post-market clinical trials for complaint determination.
  • Assist in the development and execution of associated department procedures and work instructions.
  • Assist in the development, planning and delivery of training to FA staff and other teams within the organization to ensure efficient complaint handling processes and compliance to regulatory requirements.
  • Initiate or participate in various continuous improvement projects that lead to the development of robust complaint handling processes.
  • Assist in the preparation for company audits and composing written responses to any audit findings, as assigned. Assist with the management of CAPA responsibilities related to Field Assurance complaint handling processes.
  • Perform additional responsibilities as assigned.
    1. Bachelor’s degree or equivalent combination of relevant experience, education and training.
    2. Minimum of eight (8) 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. Experience in evaluating complaints for vascular intervention, surgical/implantable, neurological interventional, or in-vivo diagnostic medical devices.
    5. Strong analytical and critical thinking skills with the ability to make sound judgments based on objective data and acquired knowledge.
    6. Excellent writing/composition skills with the ability to construct clear and comprehensive clinical/technical narratives.
    7. Excellent verbal communication skills, with demonstrated success in establishing and maintaining effective interpersonal relationships, with the ability to influence and lead others.
    8. Excellent time management skills with the proven ability to prioritize daily conflicting demands to meet strict regulatory compliance and organizational deadlines.
    9. Excellent cross-functional team collaborative skills.
    Desired Qualifications
    1. Experience with CAPA processes/project management, complaint remediation, and process improvement initiatives.
    2. Knowledge of pre-market Regulatory Affairs and Clinical Research practices and requirements.