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Product Surveillance Specialist

Location: Madison, WI, United States
Job # 12179510
Date Posted: 04-11-2019
Product Surveillance Specialist
Pay Rate: $20/Hour
M-F 40 Hours
Job Overview:
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.
  • Drives the resolution of product issues in the field through communications with appropriate parties.
  • Documents and maintains records of all complaint investigations in accordance with 21 CFR § 820.198.
  • Completes all required customer complaint related documentation in an accurate, professional and timely manner.
  1. Preferred or Desired:
    • Experience in Regulatory Affairs and/or Quality Assurance in medical devices, previous complaint handling experience.
  1. Required:
    • Bachelor’s degree in an engineering or clinical field, or an equivalent combination of relevant experience and education. (1 year of experience in Product Surveillance)
    • Medical Device experience is a plus.
    • Experience with 123 Compliance software is a plus.
    • Excellent written and verbal communication skills.
    • Detail oriented.
    • Ability to work with a sense of urgency.
    • Ability to apply critical thinking and problem-solving skills and to work collaboratively to find best solution.
    • Capable computer and Microsoft Office skills.
Please submit your resume for consideration!
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