FDA Regulatory Affairs Specialist — Remote Eligible
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Healthcare
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Quality Assurance - QA/QC
Job Description & How to Apply Below
IMMY is seeking a Regulatory Affairs Specialist – FDA to lead US submissions for in vitro diagnostic products. You will prepare and maintain 510(k), De Novo, PMA or EUA filings, and manage FDA interactions to secure and sustain market clearances.
You will monitor registrations, listings, UDI/GUDID data, labeling, and post‑market activities, ensuring compliance with FDA medical device regulations and ISO 13485. Remote-eligible within the United States.
The FDA Regulatory Affairs Specialist — Remote Eligible role at IMMY is now open for applications in OR, United States.
Our group is growing, and we are hiring a FDA Regulatory Affairs Specialist — Remote Eligible in OR, United States.
This position is for the FDA Regulatory Affairs Specialist — Remote Eligible role at IMMY.
We are seeking a motivated FDA Regulatory Affairs Specialist — Remote Eligible to join IMMY in OR, United States.
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