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FDA Regulatory Affairs Specialist

Company: VirtualVocations
Location: Spring
Posted on: April 27, 2025

Job Description:

A company is looking for a Technical Research Regulatory Affairs Specialist/SME-FDA.
Key Responsibilities

Conduct FDA regulatory affairs quality assurance audits of research projects
Develop and provide consultation on FDA-regulated device research trials
Create and deliver FDA research regulatory affairs training and education materials

Required Qualifications

At least 5 years of experience in FDA research regulatory requirements
3 years of experience in FDA clinical research protocol compliance administration
Bachelor's Degree in a technical science, engineering, or medical area
1 year of experience in developing FDA-regulated device research trials
Experience in reviewing applications submitted to the FDA CDRH

Keywords: VirtualVocations, College Station , FDA Regulatory Affairs Specialist, Other , Spring, Texas

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