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Scientist I - IVD Device Validation

Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Regulatory Affairs

Description

Come be a part of our team and our mission

At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.

We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.

BioFire Diagnostics, LLC. is looking for a validation Scientist to join our growing team! The Scientist's 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. The Scientist I is responsible for 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. The rigorously designed, executed and documented studies will be used to support submissions to the FDA and other regulatory agencies worldwide.

A cover letter must be submitted with your application.

Job Duties and Responsibilities:

  1. Manage a team of research associates performing analytical testing to support regulatory clearance of molecular diagnostic products.
  2. Design, plan and write experimental protocols and reports for analytical studies to support regulatory clearance for molecular diagnostic products.
  3. Coordinate complex laboratory testing schemes and manage timelines to maximize efficiency and meet timelines.
  4. Accurately analyze and interpret data to drive testing decisions in real-time.
  5. Write accurate and clear reports to be included with data submission to regulatory bodies for clearance of molecular diagnostic products.
  6. Contribute to the development, writing, and technical review of regulatory documents for submission to the FDA and other regulatory bodies, including pre-submission documents, 510(k) or de novo pre-market applications and product instructions for use.
  7. Communicate regularly with direct supervisor to relay project status and data summaries, technical topics or challenges, and personnel matters.
  8. Collaborate with other scientists and personnel in various company departments to develop strategies and experiments, share resources, communicate progress and observations, problem-solve, and resolve technical issues.

Training and Education: PhD in scientific discipline or equivalent; may consider exceptional candidates with a Master’s degree in Microbiology or Molecular biology and at least 3 years of relevant industry experience.

Experience: Expertise in molecular techniques, including PCR and sequencing technologies. Special attention will be given to candidates with a strong foundation in microbiology and/or infectious disease diagnostics.

Skills:

  1. Strong interpersonal skills and the ability to work with a variety of people (Research associates, Directors, Scientist, Engineers, Project coordinator/managers) from different education and cultural backgrounds.
  2. Excellent oral and written communication skills.
  3. Demonstrated ability to independently plan experiments, analyze data and troubleshoot problems in real-time.
  4. Strong organization and project management skills.
  5. Experience training, managing and mentoring others.
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