Medical Experience Analyst

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.The Medical Experience Analyst (MEA) monitors complaint activities and applies clinical, technologic and regulatory knowledge to all complaints registered at Abbott Spine, Inc., Austin, Texas. Responsibilities include:1. Monitors and reviews complaint information to determine if complete and accurate information has been recorded.2. Applies clinical knowledge to timely and thorough complaint documentation.3. Makes follow up contacts with applicable parties (e.g. sales representatives, surgeons, nurses, hospital personnel, marketing personnel, etc.) in order to gather pertinent clinical or other information in order to complete complaint files.4. Performs accurate and complete database searches and queries and summarizes data.5. Assists Quality Managers and other departments as a medical advisor resource. Proactively identifies areas for process improvements.6. Reviews/writes product investigation reports, provides and analyses trending data, including initiating formal investigations and/or corrective action requests resulting from product complaints.7. Prepares well-written MedWatch forms for FDA reporting within timelines.8. Identifies adverse MDR and complaint trending by product.9. Recognizes and alerts management to risk, legal, labeling or other product issues.QualificationsBachelor's degree in life science discipline or Biomechanical EngineeringPosition requires knowledge of the following regulations: US FDA 21 CFR Part 803, US FDA 21 CFR Part 806, Medical Device Directive for vigilance Reporting and Canadian requirements for Vigilance Reporting.· 3-5 years total medical practice experience required· Medical device experience supporting complaint handling and/or MDR reporting required· Must understand the medical conditions and procedures associated with device complaints and product technologies. Bachelor's degreeAbbott welcomes and encourages diversity in our workforce. EEO/AATo apply for this position, click here.To learn more about Abbott and view other opportunities, click here.