JOB DESCRIPTION:
Medical Events Specialist I (Operations)
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](https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and [FreeU](https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 of our Alameda, CA location in the Diabetes Care division where 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.
As Medical Events Group Specialist (Operations), you will be 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.
What You’ll Work On
- Review medical complaints and potentially reportable events, gather required additional information to determine the reportability of the complaint in accordance with regulations.
- Document filing decision rationale in the Complaint Handling System.
- Ensure timely submission of reportable medical events and malfunctions to regulatory authorities in accordance with local and international regulations.
- Monitor the status of submitted vigilance reports and ensure follow–up actions are completed in timely manner.
- Collaborate with internal teams such as customer service, Complaint evaluation group and complaint investigation team to gather necessary information for vigilance reports.
- Provide feedback and recommend solutions within the Quality team to promote accurate documentation of the complaint case.
- Stay updated on regulatory requirements, internal Quality System procedures and guidelines related to medical device vigilance reporting.
- Adapt processes and documentation to align with updated regulations.
- Interface with management and other functional areas to ensure that Potential Reportable Events (PREs) are obtained in a timely and consistent basis.
- Manage and triage the vigilance mailbox, prioritizing inquiries and ensuring timely acknowledgment and response within defined or agreed timelines.
- Coordinate cross-functional inputs and align with leadership to develop accurate, compliant responses to inquiries from Competent Authorities, Notified Bodies, commercial affiliates, and internal teams.
- Track deliverables and due dates, proactively driving follow-ups, and ensuring on-time, high-quality completion of all responses.
Required Qualifications
- Bachelors Degree in related field or an equivalent combination of education and work experience
- Minimum of 1 year of experience in Regulatory, Medical Events reporting or Quality.
Preferred Qualifications
- Ability to communicate at all levels with clarity and precision both written and verbally.
- Excellent problem-solving and critical-thinking skills.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Multitasks, prioritizes and meets deadlines in timely manner.
