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Regulatory Affairs Specialist (hybrid)

This job posting is no longer active.

Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Regulatory Affairs

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Job Title Changed To:  Regulatory Affairs Specialist


Main Accountabilities:


  • Understand, investigate regulatory history of similar products in order to assess regulatory implications for new products or change to existing products,
  • Stay abreast of regulatory changes and of application requirements and processes,
  • Develop product regulatory strategy based on history of similar products with considerations to recent changes in requirements and propose solutions to meet them,
  • Validate product labels, instructions for use, advertising and promotional materials,
  • Compile regulatory applications and files following existing procedures and documents; organize content; check regulatory applications and files for completeness and provide feedback; ensure filing and timely retrieval,
  • Assist in the execution of regulatory processes and interactions with regulatory agencies.




  • Bachelor’s degree in Science or engineering,
  • Knowledge of MD/IVDMD regulatory requirements, processes and submission types (local/regional).


Skills and Qualifications:


  • Research information and data,
  • Analyze and understand technical and scientific documents,
  • Attentive to details and to consistency,
  • Communication with internal stakeholders verbally and in writing,
  • Can work in an international environment (with a focus on China).





Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux 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.,,, 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 or contact us at [email protected].

BioMérieux 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 BioMérieux’s or its affiliates’ 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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