Complaint Resolution Professional

1 week ago


Bothell, Washington, United States React Health Holdings, LLC Full time
Company Overview

React Health Holdings, LLC is a leading manufacturer and distributor of medical equipment serving the respiratory, sleep, and cardiology patients. Our goal is to provide innovative products that comply with all regulatory requirements and meet or exceed market expectations.

About the Job
The Complaint Specialist I will focus on complaint handling processes, inputting complaints into our database system, participating in investigations, updating files, and providing timely customer responses.

Responsibilities
  • Receive and document complaints
  • Follow up with initial reporters for additional information as required
  • Perform and/or coordinate complaint investigations
  • Determine Medical Device Reporting in accordance with 21 CFR Part 803 and other international regulatory reporting
  • Create and submit MDRs to regulatory agencies within required timeframes
  • Maintain the complaint database
  • Provide complaint trending and reporting for Management Review
  • Identify and lead process improvements

Requirements
  • At least 1 year of experience in complaint handling required
  • Familiarity with electronic quality management systems
  • Medical devices/Health Industry experience
  • Experience with business environment and regulations including FDA, ISO, and EU
  • Ability to build relationships throughout the organization and work with cross-functional teams

Preferred Qualifications
  • Bachelor's degree in engineering, life sciences, or related field
  • Excellent attention to detail and project management skills

Working Conditions
The predominant work environment is an office setting, requiring minimal physical demands.

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