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

Benefits:

• Medical
• Dental
• Vision
• 401k - company match of 5% regardless of participation and up to a total of 9.5% company match if contributing 
• 4 Weeks of PTO
• 9 Paid Holidays
• Paid Winter Break from the work week between December 24 thru December 31 
• Participation in Company's Wellness Program (discounted medical premiums)
• Multiple Company Sponsored Events Each Year (catered breakfast/lunch, holiday parties, snacks)
• Stimulating work environment
• Convenient location near I-15 and Trax Station
• Free Parking

Our EEO Policy

BioFire Defense is an equal opportunity employer (M/F/D/V). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. BioFire Defense complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.