Analyst, Product Surveillance
About The Position
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 Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
Requirements
- 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.
- 0 - 2 years of experience
- Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry preferred.
Nice To Haves
- Lab Experience
Responsibilities
- 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
Benefits
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account (for High Deductible Health Plans)
- Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
- Supplemental Life Insurance
- Short Term Disability (coverage varies by state)
- Long Term Disability
- Critical Illness, Hospital coverage, Accident Insurance
- MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
- 401(k)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
