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.

     

JOB DESCRIPTION:

Specialist II Medical Events

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide 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 the 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.
• Drive improvements to standard operating procedures, training and other tools used by for the Medical Events Group 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.

Required Qualifications

• B.S. in any field with preference being in a Technical/Scientific discipline or an equivalent combination of education and work experience will be considered
• Minimum 4 years Working in a quality related role, or equivalent time in clinical laboratory, medical clinic, or nursing experience.

Preferred Qualifications

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

Apply Now

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.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Diabetes

We’re focused on helping people with diabetes manage their health 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.

     

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.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

ADC Diabetes Care

        

LOCATION:

United States > Alameda : 1360-1380 South Loop Road

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing 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