Medical Device Analyst

1 month ago


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

We are seeking a highly skilled Medical Device Analyst to join our team at BlackFish Federal LLC. As a Medical Device Analyst, you will play a critical role in reviewing, prioritizing, and analyzing adverse medical events related to medical devices submitted to the FDA.

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

Work is primarily performed in an office environment.

This document is not intended to cover or contain a comprehensive listing of all job-related activities, duties, or responsibilities that are required of the employee. Due to the nature of the industry, job tasks may be changed as necessary to meet the needs of the customer.

BlackFish Federal LLC is an equal opportunity employer providing equal employment opportunities (EEO) 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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