Clinical Field Assurance Specialist

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.

• 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.
• 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.