Role: Product Surveillance Analyst

Location: St. Paul, MN

Duration: 11 Months

Shift Timings: 6-3 or 9-6

Job Description:

Years Experience: 0 - 2 years

Skills: Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry preferred.

Education:

Four-year degree, preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis. Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.

Duties:

May perform multiple functions within the postmarket surveillance department.

Major responsibilities would include determining classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality.

Complete FDA MDR and other outside competent authority regulatory reports.