Medical Device Analyst

3 weeks ago


Hyattsville, Maryland, United States BlackFish Federal LLC Full time
Job Title: Medical Device Analyst

This position is responsible for reviewing and analyzing adverse medical events related to medical devices submitted to the FDA. The successful candidate will prioritize and process reports from device manufacturers, importers, and users, ensuring accurate coding and data entry.

Key Responsibilities:
  • Analyze MedWatch reporting forms to determine if they meet FDA's Code Blue criteria
  • Assign product, manufacturer, patient, and device problem codes
  • Enter data into the FDA proprietary database application
  • Take phone reports from the public and translate data to the MedWatch 3500 form
  • Identify reports not regulated by the Center for Devices and Radiological Health (CDRH)
Requirements:
  • Bachelor's degree in a related health science field
  • Good telephone etiquette and clinical experience
  • Team player with strong organizational skills
  • Attention to detail and ability to note changing regulations
  • Basic computer and typing skills
Preferred Qualifications:
  • Registered Nurses with a Bachelor's of Science in Nursing
Work Environment:

This position is primarily performed in an office environment.

BlackFish Federal is an equal opportunity employer providing equal employment opportunities to all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.



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