Regulatory Affairs Associate

Adaptive Biotechnologies · Remote

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Role summary

Regulatory Affairs Associate supporting submission and compliance activities for in vitro diagnostic devices across US and international markets. The role involves managing regulatory documentation, coordinating FDA submissions, and maintaining compliance files while assisting with process improvements.

What they're looking for

Bachelor's degree
2+ years regulatory affairs experience in diagnostics or pharmaceutical industry
Knowledge of FDA guidelines and quality systems regulations
Experience with IVDs, molecular diagnostics, or CLIA laboratories preferred

What you'll be doing

Assist in writing and implementing process improvements for regulatory functions
Maintain and file regulatory documents per standard operating procedures
Compile and format materials for submissions and technical file documentation
Coordinate submissions per FDA and global health authority requirements
Communicate regulatory impacts and updates to cross-functional teams

Compensation$38.56 - $57.88 hourly; equity grant and bonus eligible

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