Medical Device Reporting Specialist

3 weeks ago


Oakland, California, United States Abbott Laboratories Full time
About Us

Abbott Laboratories is a leading global healthcare company that provides innovative solutions to help people live more fully at all stages of life.

Job Description

We are seeking an experienced Medical Device Reporting Specialist to join our team. As a key member of our organization, you will be responsible for reviewing and filing medical device reports in compliance with regulatory requirements.

Your primary responsibilities will include:

  • Reviewing and documenting medical device reports in a timely manner
  • Interacting with internal teams to gather information and determine reportability
  • Performing verification of MDRs and vigilance reports
  • Supporting the development of medical event reporting guidance for new products
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree in a technical or scientific field
  • Minimum 4 years of experience in a quality-related role or equivalent time in clinical laboratory, medical clinic, or nursing experience
Preferred Qualifications

A strong background in FDA/International guidelines for drug/device safety reporting requirements would be an asset.

What We Offer

We offer a competitive salary range of $83,600 - $167,200, depending on location, as well as a comprehensive benefits package and opportunities for career growth and development.



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