Regulatory Affairs Specialist II

2 weeks ago

Lake Forest, United States Abbott Laboratories Full time

About Abbott

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis, and treatment of a range of health conditions.

Abbottâs life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. Weâre 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 Abbottâs diagnostics instruments, providing lab results for millions of people.

The position of Regulatory Affairs Specialist II (Medical Events)  is within our Infectious Disease business unit located in Lake Forest, IL. In this role you 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). This includes but is not limited to the efficient and timely review, documentation and filing of potentially reportable events

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:

  • Career development with an international company where you can grow the career you dream of .
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelorâs degree.
  • A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

WHAT YOU'LL DO

  • 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 recommends 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.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companyâs policies and practices.

EDUCATION AND EXPERIENCE YOU'LL BRING

Required:

  • BS/BA degree in field of science such as Chemistry, Microbiology, Biology, Biochemistry or Bachelorâs Degree in Nursing, Biology, Chemistry, Biochemistry, Engineering or other related technical field (or the equivalent combination of education and experience).
  • 2+ years of experience in a Regulatory Affairs or Quality role or equivalent time in a clinical laboratory, medical clinic or nursing experience.

Preferred:

  • 1+ yearsâ experience in an IVD or medical device manufacturing environment.


The base pay for this position is $57,300.00 â $114,700.00. In specific locations, the pay range may vary from the range posted.

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