Clinical Field Assurance Specialist
Company: millenniumsoft
Location: Tempe
Posted on: April 2, 2026
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Job Description:
Position : Clinical Field Assurance Specialist Location : Tempe,
AZ Duration : 6 Months Contract Total Hours/week : 40.00 1st Shift
Description: The Clinical Field Assurance Specialist I will
evaluate incoming information, and the relationship between the
product and any clinical event, and communicates event
investigation via regulatory reports within globally required
timelines. This position requires timely communication and
follow-up with customers, physicians, sales representatives,
medical journal authors, third party vendors, and international
business coordinators. This process is governed by FDA Quality
System Regulations (QSR), ISO 13485:2003, MDR/MDV and other global
regulatory requirements. It is essential that all information
received from customers, third party vendors, and Client employees
are accurately recorded into the electronic complaint-handling
database. Able to access the information provided and make MDR
reportability decisions in compliance with FDA regulatory reports
(e.g., MDR, MDV, etc.). May conduct quality checks, peer or final
approvals of complaint files prior to closure. Assures timely
complaint closures, meeting both internal and external requirements
and goals. Continuously monitors complaints for potential trends.
Responsible for the secure and accurate maintenance of the
complaint database. Reviews medical records for event information
to determine regulatory reportability or to respond to corporate
legal inquires.
Keywords: millenniumsoft, Avondale , Clinical Field Assurance Specialist, Healthcare , Tempe, Arizona
