Regulatory Affairs Specialist - Biofire
Salt Lake City, UT
About the Job
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.
Source : Biofire
