Regulatory Affairs Specialist II

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 115,000 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 The Regulatory Affairs Specialist II (Medical Events) position supports the Infectious Disease business in Lake Forest, IL on site. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision‑making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. What You’ll Work On In this role, if hired you will be responsible for the timely review, documentation, and submission of Medical Device Reports (MDRs), including international vigilance reports for the division’s products. You will be accountable for ensuring compliance with Medical Device Reporting regulations (including 21 CFR 803) and for the efficient and timely processing of potentially reportable events. 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. File 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. Perform review and approval of advertising and promotional materials to verify alignment to product labeling and regulations. Demonstrate leadership in the continuous improvement of 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 a 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. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at abbott.com, on LinkedIn at and on Facebook at The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr