Sr Medical Events Specialist

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 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
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 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.

The Opportunity
This position works out in our facilities of Lake Forest IL in the Diagnostics Division.
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.
What You'll Work On
Responsible for timely review, documentation and filing of Medical Device Reports to the FDA (US) and preparing MIR/MDI reports to rest of world for CORE Dx products. Interact with Medical Affairs, Customer Service 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 compiled for metrics, risk evaluations and various other MEG related activities. Provide support for new product launches, which includes information regarding Reportability. Assure compliance to the CORE Dx Medical Event and Quality System procedures.
MAIN RESPONSIBILITIES
• Perform assessment of potentially reportable complaints against criteria for reportability and reports are filed as necessary in compliance with regulations.
• 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 identifying and elevating required 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.
• Ensure the safety and effectiveness of products in the field by interfacing with other functional areas (e.g. Customer Service and Site Quality) responsible for complaint handling and evaluations and highlighting potential medical; clinical and/or safety issues with CORE Dx products.
• Ensure that non-conformances or potential non-conformances in the medical event reporting process are identified; documented; and resolved through effective CAPA implementation and monitoring.
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, 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 Specialist 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.
Required Qualifications

• Bachelors Degree (± 16 years)
• Experience Minimum 3 years

Preferred Qualifications

• Bachelor degree in a Technical/Scientific discipline
• Experience working in a quality related role, or equivalent time in clinical laboratory, medical, nursing experience or in the medical device field.
• Knowledge of FDA/International guidelines for drug/device safety reporting requirements preferred.

* 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
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
$71,300.00 - $142,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
HIAC Core Lab
LOCATION:
United States > Lake Forest : CP01
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
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)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf