Regulatory Scientist
Position Summary
This position is part of a team that supports analytical studies for regulatory submissions of in vitro diagnostic (IVD) products developed by BioFire Defense. Their primary responsibility is to develop, lead, and report on performance studies that demonstrate products and devices are functioning in accordance with design and regulatory requirements and specifications. Daily responsibilities will include planning and designing projects, directing and overseeing laboratory activities of Research Associates, data analysis, troubleshooting, reporting results and observations, and writing and reviewing study reports and regulatory submission documents. Work is primarily collaborative and requires the ability to effectively and respectfully communicate and coordinate with peers and supervisors.
Other key skills required:
Education
Experience
- At least two years' experience conducting research in an academic or industry environment