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Complaint Specialist

3 months ago


Irvine, United States Insight Global Full time

Must Haves:

  • Bachelor's Degree
  • 2+ years of experience in regulatory affairs or complaint handling
  • Experience owning the full lifecycle of complaint handling (opening, processing, and closing)
  • Experience drafting and submitting reports to the FDA
  • Understanding of all management standards of Good Manufacturing Practices (GMP) and US Federal Regulations CFR 820 & 803
  • Medical device experience

Plusses:

  • Experience with FDA eSubmitter and/or WebTrader

Day to Day:

A manufacturing company is seeking a temporary Complaint Specialist to join their team. This individual will be evaluating events to determine if it is a complaint and if it is reportable to the FDA, will be directly communicating with customers, and will be ensuring compliance with all regulations. This is a hybrid role working 3x a week onsite in Irvine, CA.

$25 to $35/HR

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.