Medical Events Specialist I - Alameda, CA - Full-time

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 114,000 colleagues serve people in more than 160 countries.

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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. 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 student debt program and 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.

The Opportunity

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.

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 a 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/Viglance reports, including support of data complied 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.

QUALIFICATIONS

-Associates Degree

Experience/Background

-Minimum 2 years working in a quality related role, or equivalent time in clinical laboratory, medical clinic, or nursing experience.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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.

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The base pay for this position is $65,900.00 – $131,900.00. In specific locations, the pay range may vary from the range posted.