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Abbott · 14 hours ago

Analyst, Product Surveillance

St Paul, MN

Contract

Onsite

New Grad, Entry Level

0+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking an Analyst for Product Surveillance to perform various functions within the postmarket surveillance department, including reviewing adverse events and regulatory reporting.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

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

Managing complaints from Abbott Field Reps sitting in at procedures/onsite – submitted through complaints system, assignment from the complaint in system

EPIQ complaint handling system

MS Office experience required

Qualification

FDA MDR reportingComplaint handlingPost market surveillanceMedical device experienceMS OfficeLab experience

Required

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

0 - 2 years of experience

MS Office experience required