Global Complaint Management Specialist

2 days ago


Salt Lake, Utah, United States ICU Medical Full time
Job Title

Global Complaint Management Specialist

Job Summary

The Global Complaint Management Specialist will be responsible for managing device or pharmaceutical complaints and adverse events globally. This role will involve initial triage of complaint files, assessments of reportability, escalating customer advocacy events, submitting regulatory reports in accordance with applicable regulations, referring potential safety cases to applicable departments, obtaining additional information for events, providing updates to reports, and assuring timely processing of complaint files with regards to regulatory reporting.

Key Responsibilities
  • Evaluate complaints from a patient safety perspective and complete regulatory reporting decisions per reporting requirements globally.
  • Create and submit regulatory reports to the FDA and/or Regional Competent Authority.
  • Obtain additional information for events as needed.
  • Escalate and/or assist with customer advocacy issues as they occur.
  • Manage the complaint through its life-cycle from registration, sample retrieval, follow-up, investigation, and closure when required.
  • Provide accurate information to customers during information gathering processes and within replies.
Requirements
  • Experience with or knowledge of medical terminology and how medical/pharmaceutical products are typically used in a clinical setting.
  • Basic computer and software skills.
  • Ability to communicate effectively with internal and external customers.
  • Demonstrate ability to collect, analyze, and interpret complaint and adverse event information.
Education and Experience
  • Required: Bachelor of Science Degree in Nursing, Bio-Medical Engineering, Pharmacy, Medical Technology/Clinical Laboratory Science, or other scientific field.
  • Preferred: Minimum 1 year of experience in a healthcare environment, and/or within a quality/compliance/regulatory organization in an FDA-regulated business.
Travel Requirements

Typically requires travel 0-10% of the time.

Physical Requirements and Work Environment

This is largely a sedentary role. This job operates in a professional office environment and routinely uses standard office equipment.



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