Regulatory Affairs Specialist II (Medical Events)

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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 109,000 colleagues serve people in more than 160 countries.

About Abbott

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.

Abbott's life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. 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.

The position ofRegulatory Affairs Specialist II (Medical Events) is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will be 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 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 an 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 compiled 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.
    Develop internal procedures and tools.
    Demonstrate commitment to the development, implementation and effectiveness of Abbott
  • QualityManagement System per ISO, FDA, and other regulatory agencies.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.


EDUCATION AND EXPERIENCE YOU'LL BRING

Required:
  • BS/BA degree in field of science such as Chemistry, Microbiology, Biology, Biochemistry or Bachelor's Degree in Nursing, Biology, Chemistry, Biochemistry, Engineering or other related technical field (or the equivalent combination of education and experience).
  • 4+ years of experience in a Regulatory Affairs or Quality role or equivalent time in a clinical laboratory, medical clinic or nursing experience.


Preferred:
  • 1+ years' experience in an IVD or medical device manufacturing environment.


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: http://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.

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