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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 Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 to the FDA (US), Medical Problem Reports to Health Canada, Medical Incident Reports to the EU/EFTA including France, and Medical Device Incident reports to the rest of world for the division's products. Interact with 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. Work with Complaint Investigation Group to gather the appropriate information from a returned device investigation for submission of an MDR/Vigilance follow up report. Perform verification of MDRs/Viglance reports, including data complied for metrics, risk evaluations and various other MEG related activities. Support development of Medical Event Reporting guidance for new products. Provide consultation or support to new product teams regarding Reportability. Assure compliance to the ADC Medical Event and Quality System procedures.

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.

•Document filing decision rationale in the Complaint Handling System.

•Filing of all medical events and reportable malfunctions within the required timeframe.

•Create compliant and practical solutions to cross-functional teams in order to promote accurate documentation of the complaint case, including MEG processes from a broader scale perspective.

•Responsible for maintaining the Malfunction Reportability Assessment Matrix (MRAM), including updates to the Reportable Confirmed Malfunction List (RCML).

•Demonstrates subject matter expertise; guidance, and training to other members of the Medical Events Group as well as to other functional departments.

•Additional Responsibilities:

•Drive improvements to standard operating procedures, training and other tools used by for the Medical Events Group as required.

•Perform other related duties and assignments as required.

•Accountable for meeting the compliance requirements for Medical Device Reporting (803), including but not limited to: the efficient and timely review, documentation and filing of potentially reportable events.

•Interface with MEG management and other functional areas, as required, 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.

Accountability/Scope/Budget

Accountable for meeting the compliance requirements for Medical Device Reporting (803), including but not limited to: the efficient and timely review, documentation and filing of potentially reportable events.

Interface with MEG management and other functional areas, as required, 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

Bachelors Degree with preference being in a Technical/Scientific discipline or equivalent combination of education and work experience

Experience/Background

RN, BSN, or Medically trained professional with knowledge of FDA/International guidelines for drug/medical device safety reporting requirements preferred.

Knowledge of FDA/International guidelines for drug/device safety reporting requirements preferred.

Minimum 4 years

Working in a quality related role, or equivalent time in clinical laboratory, medical clinic, or nursing experience.

Apply Now (https://www.jobs.abbott/us/en)

• 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: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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 www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com