Regulatory Affairs Associate
$38.56 - $57.88 per hourAdaptive Biotechnologies
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.
Responsibilities
- 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
Requirements
- 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
Compensation: $38.56 - $57.88 hourly; equity grant and bonus eligible
Vacancy posted 4 days ago
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