Regulatory Affairs Specialist

5 hours ago


Salt Lake, Utah, United States BioFire Defense, LLC Full time
Job Summary

BioFire Defense, LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements for our in vitro diagnostic (IVD) products.

Key Responsibilities
  • Support the development and validation of IVD reagent test kits and their associated systems.
  • Monitor and interpret new US and international regulations, providing updates to relevant teams.
  • Assist with the interpretation of regulatory rules or rule changes and ensure their proper communication through corporate policies and procedures.
  • Participate in labeling review and recommend changes for regulatory compliance.
  • Review and approve product labeling, advertising, and promotional materials related to BioFire's regulated products.
  • Prepare and submit documents to regulatory bodies as needed.
  • Support communications with regulatory bodies and maintain contact logs.
  • Assist with regulatory strategy development and transition planning for new IVD products.
  • Support GUDID project and UDI compliance for all IVDs.
  • Establish and conduct post-market surveillance for IVD and combined use products.
  • Support post-market activities, including adverse event reporting and field actions.
  • Review and assess product change impacts for US, Health Canada, and international markets.
  • Work with Quality Assurance Team on audits, complaint investigations, NCRs, CAPAs, medical device reporting, and recalls.
Requirements
  • BA/BS, preferably in a scientific field or equivalent years of regulatory/technical experience.
  • Certification of ISO 13485 Lead Auditor Training with 21 CFR 820 (preferred, may be acquired post-hire).
  • 3-5 years of experience in regulatory or related technical field.
  • Excellent written and verbal communication skills.
  • Solid organization skills, including attention to detail and multitasking skills.
  • Strong working knowledge of Microsoft Office and project management skills.
  • Ability to work independently and proceed with priority objectives with minimal supervision.
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


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