Principal Regulatory Affairs Specialist (Medical Events)

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, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Lake Forest, IL location in the Infectious Disease , Diagnostics Division. We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people. The Principal Regulatory Affairs Specialist (Medical Events) will be responsible for timely review, documentation and filing of Medical Device Reports, including international vigilance reports for the division's products. Accountable for meeting the compliance requirements for Medical Device Reporting regulations including (803). The Principal Regulatory Affairs Specialist (Medical Events) but is not limited to the efficient and timely review, documentation and filing of potentially reportable events. What You'll Work On Review medical complaints and potentially reportable events for the purpose of researching and gathering additional information needed to determine MDR and/or Vigilance reportability. Interact with cross-functional teams (e.g., Customer Service, Complaint Evaluations Group and Complaint Investigations Group) to gather appropriate information to determine whether a complaint requires an MDR and/or Vigilance report and/or submit an MDR/Vigilance follow up report. Document filing decision rationale in the Complaint Handling System. Filing of all medical events and reportable malfunctions within the required timeframe. Provide feedback and recommend solutions within the Quality team to promote accurate documentation of the complaint case. Assist in maintaining the Malfunction Reportability Assessment Matrix (MRAM), including updates to the Reportable Confirmed Malfunction List (RCML). Perform verification of MDRs/Vigilance reports, including support of data compiled for metrics, risk evaluations, and various other activities. Assure compliance to the division's Medical Event and Quality System procedures. Interface with management and other functional areas to ensure that Potential Reportable Events (PREs) are obtained in a timely and consistent basis. The documentation of the work of the Medical Event Analyst is scrutinized by the Regulatory Agencies on a regular basis and compliance is measured by the accuracy and completeness of these documents. Failure to properly evaluate or report complaints could result in observations from regulatory agencies. Develop internal procedures and tools. Demonstrate commitment to the development, implementation, and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies. Required Qualifications BS/BA degree in field of science such as Chemistry, Microbiology, Biology, Biochemistry or Bachelor's Degree in Nursing, Biology, Chemistry, Biochemistry, Engineering, or other related technical field (or the equivalent combination of education and experience). 4+ years of experience in Regulatory Affairs or Quality role or equivalent time in a clinical laboratory, medical clinic, or nursing experience. Preferred Qualifications 1+ years' experience in an IVD or medical device manufacturing environment. 2 -3 years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory areas are preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas. Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents. #J-18808-Ljbffr Abbott (abbottcareers2 board)