Position Overview

INNOVATION STARTS WITH YOU

Are you interested in working for an organization that is making a difference in people’s lives every day? We’re a medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We’re a high-growth, customer-focused company with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what
MicroVention®TERUMOhas to offer.



Position Overview
Responsible for the processing of high-level, critical product complaints and regulatory assessment activities for Class II/III neurovascular medical devices, ensuring compliance to domestic and international regulatory requirements and corporate objectives. Responsible for the management and movement of all reportable adverse event complaint fileswhile maintaining compliance to internal standards/procedures and applicable external industry regulations. Execute continuous improvement activities. Interacts with distributors, manufacturing facilities, and MicroVention Europe customer service.
  • Reviews, analyzes, and processes complex and critical product complaints from domestic and international customers that are associated with adverse events. Investigates complaints by gathering sufficient information from customers, field representatives, physicians, clinical staff, and internal resources for thorough understanding and documentation of the event. Determines internal complaint codes and patient outcome codes. Appropriately documents complaint investigation activity in reportable complaints per Good Documentation Practices in the electronic Complaint handling system.
  • Interprets complaints and makes regulatory reporting assessments per FDA MDR regulation (21 CFR 803), Vigilance Medical Device Directive (MEDDEV), Health Canada MDIR, and TGA medical device reporting regulations. Applies knowledge of medical device regulatory requirements to construct appropriate decision tree rationales to support U.S. eMDR and International (OUS) Vigilance reporting decisions.
  • Prepares U.S. medical device reports (eMDRs) and OUS regulatory Vigilance reports to management for approval for submission to Regulatory agency by the report deadlines. Determines complaint codes, patient outcome codes, and MedWatch/IMDRF codes.
  • Manages and drives the progress and movement of open reportable complaint files from initiation to closure. Monitors follow-up communications received from customers and escalates potential changes in reportability decisions to GRR management.
  • Provides updates and reports of open complaint activity and pending action items to GRR management. Prepares regular reports to track regulatory report due dates and action items for open reportable complaints. Prepares applicable database queries to support GRR activities.
  • Composes clinically accurate and grammatically correct written event summaries and narratives for adverse event reports.
  • Reviews reportable complaint files for consistent and timely closure, ensuring accuracy and completion of complaint information, as well as thorough documentation of complaint investigation activity. Drives timely closure of investigation records and complaint files through communication with Failure Analysis team members and other internal partners as needed. Closes assigned reportable complaint files.
  • Assists in the collection of information for regulatory inquiry responses.
  • Identifies discrepancies in product investigation root cause/conclusions and collaborates with Failure Analysis Lab engineering and/or engineering staff for potential revisions, as needed, for inclusion in regulatory reports and customer responses. Coordinates and drives the completion of product evaluations to meet regulatory report submission deadlines.
  • Interfaces with clinical research associates to address Serious Adverse Event (SAE) notifications forwarded from MVI/MVE clinical trial databases. Creates complaint files for device-related adverse events associated with clinical trials.
  • Constructs clearly written and grammatically sound customer response letters.
  • Assists and supports management in the review of reportable complaint files in preparation for, and during, company audits.
  • Assists in the development, planning, and delivery of training to GRR staff to ensure efficient processing of reportable complaint files and compliance to regulatory requirements.
  • Assists in the development and execution of associated department procedures and work instructions.
  • Initiates or participates in various continuous improvement projects.
  • Performs additional responsibilities as assigned.
  • Required Qualifications
    1. Bachelor’s degree or equivalent combination of relevant experience, education, and training.
    2. Five (5) years of complaint handling/post-market surveillance experience.
    3. Five (5) years preparing and submitting eMDRs and Vigilance reports forClass II and Class III devices.
    4. Experience in evaluating complaints for vascular intervention, surgical/implantable, neurological interventional, or in-vivo diagnostic medical devices.
    5. In-depth knowledge of FDA 21 CFR part 803/820, Vigilance (MEDDEV), and Canadian adverse event reporting regulations for Class II/III medical devices.
    6. Excellent time management skills with the proven ability to prioritize daily conflicting demands to meet strict regulatory compliance and organizational deadlines.
    7. Strong analytical and critical thinking skills with the ability to make sound judgmentsbased on objective data and acquired knowledge.
    8. Excellent writing/composition skills with the ability to construct clear and comprehensive clinical/technical narratives.
    9. Excellent verbal communication skills, with demonstrated success in establishing and maintaining effective interpersonal relationships.
    10. Excellent cross-functional team collaborative skills.
    Desired Qualifications
    1. Direct clinical experience in the hospital/clinical environment in the vascular interventional lab (i.e. radiology, neurology, cardiology).
    2. Clinical research experience related to adverse event reporting for clinical trial devices

    Additional Information
    • The primary work location for this position is Aliso Viejo, CA (company headquarters)
    • Candidates must be eligible to work in the U.S. and not require visa sponsorship.

    Comments
    MicroVention®TERUMOwas founded in 1997, employs approximately 2,800 worldwide, and has experienced double-digit revenue growth year-over-year 3 years running. Recognized as one of the “Top Workplaces” in Orange County, California, we have a thriving culture that is innovative, customer-focused, clinically driven, demonstrates a team spirit, and empowers its employees to challenge the status quo. “MicroVention®TERUMO…Innovation Starts with You”.