JOB DESCRIPTION:The OpportunityThe 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 OnIn 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.
In addition:
- 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: https://abbottbenefits.com/
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
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.
JOB FAMILY:Regulatory Operations
DIVISION:ID Infectious Disease
LOCATION:United States > Lake Forest : J55
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
