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.