BioFire Defense is an Equal Opportunity Employer (M/F/D/V).


Scientist 1, Regulated Products
Posted: 07/31/2018



Full-Time Regulated Products

Position Summary:

The scientist’s primary responsibilities are to support a broad range of regulatory functions at BioFire Defense. These responsibilities may include providing regulatory input on new and existing systems (instrument, firmware, software, reagents), writing/reviewing protocols and reports to support regulatory submissions, preparing submission documents, integrating with the Quality System, reviewing labeling, interfacing with subcontractors, writing standard operating procedures (SOPs) and work instruction documents (WIDs) relevant to regulatory issues, post-market surveillance of IVD products, implementation of compliance with new regulations and guidance, and grant/proposal writing.

  • Collaboration with other scientists and personnel in multiple company departments is required to understand the products and resolve technical issues. Excellent writing skills are integral. Contributions to literature, conferences, funding proposals, and patent applications are expected.

Training and Education:

  • Requires a PhD in scientific discipline or equivalent; may also include exceptional non-PhDs with demonstrated capabilities.
  • Excellent writing skills are integral.
  • Minimum of 3 years of experience in a research and/or development environment with additional experience in regulatory compliance preferred.
  • Requires proficient technical writing skills.

Benefits and Compensation:

  • We offer competitive salaries
  • Vacation/holiday pay
  • Medical benefits
  • Stimulating work environment

If you are interested in this position please send us your resume
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