Clinical Complaint Specialist

Sound United · Irvine, California, United States

Location
Irvine
Job Type
Full time
Posted
July 08, 2026

Job Description

Job Summary

The Clinical Complaint Specialist is responsible for the clinical assessment, evaluation, and processing of medical device complaints in support of regulatory compliance and product safety activities. This role applies clinical expertise to evaluate complaint events, assess potential patient impact, determine regulatory reportability, support investigations, and ensure accurate complaint documentation. The Clinical Complaint Specialist partners cross-functionally to support complaint handling, post-market surveillance, and continuous improvement initiatives.

Duties & Responsibilities

  • Review, evaluate, and process medical device complaints in accordance with applicable regulations, company procedures, and quality system requirements.
  • Perform clinical assessments of complaint events to determine severity, potential patient impact, and device-relatedness.
  • Evaluate complaints for regulatory reportability, including Medical Dev...
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