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 109,000 colleagues serve people in more than 160 countries.
Our location in Alameda, CA currently has an opportunity for a Medical Events Specialist. The Medical Events Specialist is 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. 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 DO
- 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/Vigilance 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.
EDUCATION AND EXPERIENCE YOU’LL BRING
Associates Degree or an equivalent combination of education and work experience
Minimum 2 years working in a quality related role, or equivalent time in clinical laboratory, medical clinic, or nursing experience.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com/pages/candidate.aspx
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.