Medical Events Specialist I

1 day ago


Oakland, California, United States Abbott Laboratories Full time

Unlock a Fulfilling Career at Abbott Laboratories

About Us

Abbott is a global leader in healthcare, dedicated to helping people live more fully at all stages of life. Our portfolio of innovative technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.

Job Summary

We are seeking an experienced Medical Events Specialist I - Compliance Expert to join our team. This role will be responsible for timely review, documentation, and filing of Medical Device Reports to regulatory authorities worldwide.

Responsibilities
  • Review medical complaints and potentially reportable events 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 ensure follow-up actions are completed in a timely manner.
  • Collaborate with internal teams to gather necessary information for vigilance reports.
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.
  • Ability to communicate clearly and precisely 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 environment.
What We Offer

As a valued member of our team, you will enjoy:

  • A competitive salary range of $65,900.00 – $131,900.00 (dependent on location).
  • A comprehensive benefits package, including health insurance, retirement savings plan, and tuition reimbursement.
  • Ongoing career development opportunities with a global company.


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