Regulatory Affairs Specialist

Scientific/R&D Salt Lake City, Utah

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Description

The RA Market team is looking for a Regulatory Affairs Specialist to support global regions in dynamic regulatory activities.
The RA Market team based in France (Lyon) and the United States (Salt Lake City) is in daily contact with the local regulatory teams (subsidiaries and distributors) in order to guarantee the regulatory compliance of our IVD products (reagents, instruments and software) in the EME, AFRICA, ASPAC, and LATAM regions.
Reporting to the RA Market Manager, your main responsibilities will include:
  • Being the privileged point of contact point with subsidiaries and distributors. Leading regular follow-ups with in-country contacts (progress of submission files, new regulations, etc.) and working closely with regional RA and other global functions.
  • Oversight of RA activities for a range of products, including:
    • Contributing to the development of a regulatory strategy.
    • Coordination and preparation of registration and renewal dossiers within the defined deadlines, and providing these deliverables to local regulatory contacts.
    • Ensuring the traceability of shipments in our regulatory database and correct reporting.
    • Coordinating activities to answer questions from global health authorities, and following-up on regulatory activities until approval is received.
    • Participating in regulatory watch for a group of countries in order to identify if any regulation change has an impact on the product development, and/or leads to new regulatory activities.
    • Contributing to different working groups for transversal projects.
 
Position Requirements:
  • Bachelor's Degree in a scientific discipline is a plus.
  • Regulatory Affairs Specialist: 2+ years of professional experience in Regulatory Affairs, either in medical devices or a regional position.
  • The ability to speak and/or write in another language is a plus.
 
Skills:
  • Analyze/understand regulatory requirements, identify solutions, and provide directions for proper implementation. 
  • Routine problem solving.
  • Development of regulatory rationales, including the justification of the reasoning behind these rationales.
  • Ability to communicate to internal stakeholders and representatives from regulatory agencies.
  • Ability to work comfortably in an international environment.

    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 [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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