Regulatory Affairs Assistant

Scientific/R&D Salt Lake City, Utah


Description

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)
  • Bachelor’s degree in science-related field or equivalent
  • 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

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at careers@biofiredx.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).