Product Surveillance Analyst

3 weeks ago


Burlington, United States The Fountain Group Full time

Currently seeking a Product Surveillance Analyst for a prominent client of ours. This position is located in Burlington, MA. Details for the position are as follows:

Job Description:

  • Shift: Monday-Friday 1st shift.
  • Pay: $33-$35/hr depending on experience.
  • This is a temporary assignment that is slated for 7 months with possibility for extension or conversion based on performance and budget.
  • Position is responsible for skimming through qualitative patient data (what is happening in the field with the product - mostly from hospitals) determining whether or not a complaint is submittable to the FDA
  • Position is also responsible for determining classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality. Including, completing FDA MDR and other outside competent authority regulatory reports.
Qualifications:
  • Recent bachelor's degree graduate with a discipline withing biomedical engineering preferred.
  • Exposure to FDA regulations within academic or professional environment.


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