Medical Device Analyst

3 days ago

Hyattsville, Maryland, United States HeiTech Services, Inc. Full time
Job Title: Medical Device Analyst

We are seeking a highly skilled Medical Device Analyst to join our team at HeiTech Services, Inc. The successful candidate will be responsible for reviewing, prioritizing, and analyzing adverse medical events related to medical devices submitted to the Food and Drug Administration (FDA).

Key Responsibilities:
  • Review and analyze MedWatch reporting forms to determine if they meet the designated Code Blue criteria as identified by the FDA.
  • Assign the appropriate product, manufacturer, patient, and device problem codes that correlate with the patient consequences that occurred due to the use of the device.
  • Enter the product code, MFR shortname, patient and device codes into the FDA proprietary database application.
  • Take phone reports from the general public and translate the 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.
  • Participate in team meetings to discuss coding and other processing issues.
  • Interact with Administrative, Data Entry, Quality Control, and Editor staff to process the reports according to quality guidelines of the contract.
  • Query databases for information needed in the processing of the reports.
  • Ensure the accuracy of data entered into critical fields, per coding principles and procedures and the Standard Operating Procedures (SOPs).
  • Perform data entry functions as needed; and provide quality assurance of the entered data providing critical feedback to data entry staff using a database designed to capture, track, and report errors.
  • Perform coding in accordance with FDA instructions for coding and ICH Coding Principles for documents.
  • Perform quality control and quality assurance procedures to ensure the appropriate selection of codes.
  • Interface with internal users as well as external stakeholders.
  • Apply and use MS Office Suite tools Microsoft Word and Microsoft Excel.
  • Review and retrieve system data, match output with specifications in accordance with Standard Operating Procedures and resolve discrepancies.
Requirements:
  • Bachelor's degree in related health science fields such as nursing, pharmacy, veterinary, and/or certified licensed technicians as appropriate for each center.
  • Good telephone etiquette.
  • Clinical experience in the different medical specialties.
  • Team player, good organizational skills, flexible, open to feedback, and sensitive to time-related deadlines.
  • Attention to detail and ability to note and implement the changing regulations and procedures.
  • Basic computer and typing skills.
Preferred Qualifications:
  • Registered Nurses with a Bachelor's of Science in Nursing are preferred, but Licensed Practical Nurses will be considered based on clinical experience.

We are an Equal Opportunity/Affirmative Action Employer. All qualified Applicants will receive consideration for employment without regard to race, color, national origin, sex, religion, age, sexual orientation, disability or veteran status.

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