7 Regulatory Affairs Specialist II Jobs in Forest, IL
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Abbott is Hiring a Regulatory Affairs Specialist II Near Forest, IL
About AbbottDiagnostic testing is a compass, providing information that helps in the prevention, diagnosis, and treatment of a range of health conditions.
Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. 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 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 AbbottAt Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And 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 .
- 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 bachelor’s 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.
- 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 company’s policies and practices.
- 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).
- 2 years of experience in a Regulatory Affairs or Quality role or equivalent time in a clinical laboratory, medical clinic or nursing experience.
- 1 years’ experience in an IVD or medical device manufacturing environment.
Job Summary
Full Time
Transportation
$75k-96k (estimate)
08/28/2024
09/06/2024
abbott.co.nz
TORONTO, ONTARIO
25 - 50
1981
Private
JOHN J. HUMPHREYS
<$5M
Transportation
Related Companies
About Abbott
Abbott is a financial brokerage firm that offers business, personal and health insurance, and home loan services for individuals.
The job skills required for Regulatory Affairs Specialist II include Regulatory Affairs, ISO, Customer Service, Chemistry, Quality Management System, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Specialist II. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Specialist II. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Affairs Specialist II positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Specialist II, it can be promoted into senior positions as a Regulatory Affairs Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Specialist II. You can explore the career advancement for a Regulatory Affairs Specialist II below and select your interested title to get hiring information.
