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State Licensed Medical Device Analyst

7/3/2025

N/A

Job Summary

A company is looking for a Medical Device Safety Analyst.

Key Responsibilities
  • Conduct medical reviews, including in-house review of Case Report Forms (CRFs) and quality assurance of data listings
  • Manage activities associated with clinical studies, including regional contract CRAs and budget organization
  • Provide medical support for adverse event reporting and communication, including documentation preparation for regulatory authorities


Required Qualifications, Training, and Education
  • Bachelor's degree in Nursing or higher with a minimum of 3-4 years' experience in the medical device industry
  • Minimum of 5 years direct patient care experience as a Registered Nurse preferred
  • Expert understanding of global Medical Device regulations such as FDA and EU-MDR
  • Sound knowledge of device risk management and associated documentation
  • Proficiency in computer applications, including Windows, Word, and Excel

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