Medical Event Specialist
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Job Location:
Lake Forest, CA - USA
Monthly Salary:
$ 61300 - 122700
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
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. Youll 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 bachelors 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
Were 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 Abbotts diagnostics instruments providing lab results for millions of people.
We are looking for a Medical Event Specialist to support our diagnostics team in Lake Forest IL. They are 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 divisions 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.
Responsibilities
- 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/Viglance reports including support of data complied for metrics risk evaluations and various other activities.
- Assure compliance to the divisions 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.
Qualifications
- Associates Degree (minimum requirement) with preference being in a Technical/Scientific discipline or an equivalent combination of education and work experience.
- Bachelors Degree is preferred.
- Minimum 2 years working in a quality related role or equivalent time in clinical laboratory medical clinic or nursing experience.
- RN BSN or Medically trained professional with knowledge ofFDA/International guidelines for drug/medical device safety reportingrequirements preferred
- Strong data analysis skills with the ability to interpret complex datasets identify trends generate insights and present findings in a clear and actionable format preferred
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: 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 on LinkedIn at and on Facebook at
The base pay for this position is
$61300.00 $122700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
CRLB 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: EEO is the Law link - Espanol: Experience:
IC
Key Skills
- Marketing
- Catering
- Organizational skills
- Hospitality Experience
- Management Experience
- HubSpot
- Event Planning
- Events Management
- Project Management
- Event Marketing
- Leadership Experience
- negotiation
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
