Product Surveillance Specialist (Medical Device)

at Accuray Incorporated (view profile)
Location Madison, WI
Date Posted July 11, 2019
Category Medical Device
Job Type Full-time
Address 1240 Deming Way

Description

Please apply on Accuray's website:  here

 

The Product Surveillance Specialist effectively implements the complaint handling process and processes complaints in a uniform and timely manner according to regulatory requirements and company practices and policies.

 

  • Evaluates complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting and any other worldwide regulatory requirements.
  • Documents and maintains records of all complaint investigations in accordance with 21 CFR § 820.198.
  • Develops, prepares, and analyzes trend reports for complaints; monthly or quarterly as required.
  • Communicates results with worldwide customer support personnel as well as other internal departments, i.e., Marketing, R&D, Customer Service and Technical Services.
  • Investigates and develop solutions to procedure and process related issues.
  • Completes all required customer complaint related documentation in an accurate, professional and timely manner.
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