Device Adverse Event Reporting Expert

3 weeks ago


Hyattsville, Maryland, United States BlackFish Federal LLC Full time

We are looking for an experienced Device Adverse Event Reporting Expert to join our team at BlackFish Federal LLC. In this role, you will provide critical support to device manufacturers, health care providers, and user facilities in submitting adverse event reports to the U.S. Food and Drug Administration (FDA).

Your primary function will be to identify, investigate, and resolve any issues that could preclude a reporter from successfully submitting their adverse event report to FDA. You will conduct quarterly User Facility audits to ensure the most current UF information is on record with FDA.

You will work closely with device manufacturers, User Facilities, and reporters via phone and email to resolve data anomalies that prevent the acceptance of their adverse event report. This is a challenging role that requires strong analytical skills, attention to detail, and excellent communication skills.

As a Device Adverse Event Reporting Expert, you can expect a salary of $70,000 per year, plus benefits. If you have experience in regulatory affairs and are passionate about helping others, we encourage you to apply.



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