Product Surveillance Analyst - The Fountain Group

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.