Medical Device Vigilance Specialist
2 weeks ago
About Abbott
Abbott is a global leader in healthcare, dedicated to helping people live more fully at all stages of life. Our diverse portfolio spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.
Our Commitment
We are committed to empowering our employees to grow, learn, and care for themselves and their families. We offer:
- Career development opportunities with an international company where you can grow your career.
- 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 through our student debt program, Freedom 2 Save, 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.
The Opportunity
This role is responsible for timely review, documentation, and filing of Medical Device Reports to regulatory authorities, including the FDA (US), Health Canada, and the EU/EFTA. The incumbent will ensure compliance with Medical Device Reporting regulations, including (803).
Duties
- Review medical complaints and potentially reportable events, gather required additional information to determine reportability 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.
- Monitor the status of submitted vigilance reports and complete follow-up actions in a timely manner.
- Collaborate with internal teams to gather necessary information for vigilance reports.
- Provide feedback and recommend solutions within the Quality team to promote accurate documentation of complaint cases.
- Maintain 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.
- 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.
Requirements
To be successful in this role, you will need:
- Bachelor's Degree in a related field or equivalent combination of education and work experience.
- Minimum 1 year of experience in Regulatory and 1 year of experience with Medical Events reporting.
Preferred Qualifications
The ideal candidate will have:
- 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.
Estimated Salary: $65,900 - $131,900
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