Clinical Field Assurance Specialist
Clinical Field Assurance Specialist
Posted on :
12-04-2025
Employer Active
1 Vacancy
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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 followup 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 complainthandling 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.
Required Experience:
Unclear Seniority
Employment Type
Full Time
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