Regulatory Affairs Assistant
BioFire Diagnostics, Inc
 Salt Lake City, UT

BioFire Diagnostics, LLC is looking for a Regulatory Affairs Assistant to join our growing Regulatory Affairs team. The Regulatory Affairs Assistant will have the opportunity to:

  • Acquire hands-on learning experiences with regulations within the medical device industry
  • Assist members of the Regulatory Affairs team by providing organizational and informational support for global regulatory activities
  • Gain exposure to the development process associated with bringing new products to market.

Principal Job Duties and Responsibilities

  • Work cross-functionally with regulatory specialists, key internal departments, and external regulatory bodies to support product submissions
  • Coordinate and collect information from various departments (e.g., R&D, Clinical, QA, Engineering, etc.) to support regulatory projects, as needed
  • Coordinate and respond to requests from global regulatory agencies
  • Assist with regulatory assessments and strategies for proposed change notifications international jurisdictions
  • Process notarization & legalization of registration documents
  • Maintain and organize department spreadsheets
  • Participate in the review of new regulations and development of internal procedures
  • Assist with follow-up and data management for post market surveillance activities

Minimum Qualifications (must-haves)

  • Minimum- Actively enrolled in 4 year degree in a science field
  • Excellent written and verbal communication skills
  • Proficient on basic computer programs: Microsoft Word, Excel, and PowerPoint – Adobe Acrobat and Visio knowledge a plus
  • Strong organizational and interpersonal skills
  • Must be a permanent resident of the U.S. or U.S. citizen
  • Previous lab and/or medical device experience a plus but not required

Skills and Qualifications

  • Strong organizational and interpersonal skills
  • Hands-on, action-oriented, continuous improvement minded
  • Proven ability to handle multiple projects and meet deadlines
  • Willingness to work with changing priorities with enthusiasm
  • Self-starter, with the ability to work and learn independently

Please Note: An electronic version of the job description must be submitted to before the salary analysis can be performed and the job can be posted.

Justification for Position

The department is highly prolific and has many concurrent projects, as well as many more to come in 2020 and 2021. As the company has grown into working on multiple pipeline projects in parallel, as well as meeting global registration requirements, the Regulatory processes that were once handled between a few personnel has grown into processes that require more much more time and attention to accomplish deliverables and maintain compliance efficiently. Expansive projects such as EU IVDR compliance, increasingly complicated international registrations (particularly in the ASPAC region), alignment with the BioMerieux TrackWise system, and the addition of multiple panels, including COVID panels, necessitate additional personnel to handle more routine and time consuming tasks, in order for more senior employees to focus on projects that require additional expertise.

The Regulatory Affairs department previously hired an intern to fill this role, but found that the position required a more developed, committed individual. Therefore, a Regulatory Affairs Assistant position is being requested, with hopes that this individual might learn and grow within the department or company.