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:

• Experience with microbiology and molecular biology principles, tools, and techniques
• Experience with PCR and PCR applications
• Experience with laboratory practices
• Knowledge of statistical analysis
• Attention to detail, critical thinking, trouble shooting, and problem solving skills
• Ability to collaborate in a fast-paced environment
• Proficiency with Microsoft Office Suite

• May be required to obtain and maintain a DoD Personnel Security Clearance

   

Education

• Ph.D. degree with emphasis in a science, or related field

• Exceptional candidates with a Master's degree and at least five years of relevant industry experience may also be considered

   

Experience

• At least two years' experience conducting research in an academic or industry environment