Regulatory Affairs Specialist I

bioMerieux Inc.
United States, Utah, Salt Lake City
May 12, 2025
Regulatory Affairs Specialist I Location: Salt Lake City, UT, United States Position Type: Unfixed Term Job Function: Regulatory Affairs Share: share to e-mail Share on Facebookshare to facebook Tweetshare to twitter Share on LinkedInshare to linkedin Apply Now > A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada. Come and join a family-owned global company with a long-term vision, and a human-centered culture. Description The Corporate Regulatory Affairs LCM (Life Cycle Management) department is looking for a Regulatory Affairs Specialist in a dynamic regulatory context. The RA LCM team is a major player in the process of maintaining IVDs products on the market, in order to guarantee regulatory compliance with changes made to these products (reagents, instruments and software) in all of the regulated countries in the world. This team is in charge of evaluating the regulatory impacts and managing the process associated with submissions in the context of product changes, interfacing with the production sites on the one hand, and the local regulatory teams based within the subsidiaries and distributors worldwide on the other hand. Job Duties Reporting to the LCM RA Manager, your main missions / responsibilities will be: - Be the RA representative in the project team in charge of the change of a product, or a group of products, - Assess the regulatory impact of this change in the countries where this / these product (s) is / are registered, - Prepare the files associated with the changes, - Monitor and follow submissions and interactions with local RA or health authorities until the approval of these changes in support of local regulatory teams, - Guarantee the traceability of regulatory activity linked to the change, - Integrate and implement new local regulatory requirements related to changes, - Contribute to the development of RA tools / Corporate tools and processes related to change management, - Organize, update, and maintain regulatory documentation in accordance with company policy and procedures. - Assist or participate in audits when needed - Contribute to different working groups. Minimum Qualifications: Bachelor's degree. Science background is preferred. 3+ years in regulatory affairs, medical device/IVD industry required or MS degree with 1 year in regulatory affairs, medical device/IVD industry required 1+ year experience with FDA Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at recruitment@biomerieux.com. BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. 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 BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS). Share: share to e-mail Share on Facebookshare to facebook Tweetshare to twitter Share on LinkedInshare to linkedin Apply Now >