Clinical Affairs and Regulatory Affairs  

Approvals from the health authorities in many countries are required to commercialize our diagnostic tests.

Clinical Affairs is in charge of designing and conducting studies that will be used for regulatory submissions, which provide evidence that our products are safe and effective.

Regulatory Affairs is responsible for gathering and providing compliant documents to health authorities all over the world, either for initial registrations, renewals or in case of product changes.

We seek the following profiles:

  • Clinical Scientists: design clinical trials, select and qualify trial sites, ensure monitoring during the entire trial, analyze and present the data in a concise reports that are easy to understand for regulatory agencies;
  • Data Managers: design, validate and maintain the clinical trial database according to the study plan and are responsible for data integrity and quality;
  • Internal Lab Technicians: perform testing for clinical trials, and are also in charge of trainings and logistics;
  • Regulatory Affairs Specialists: do a regulatory watch, translate regulatory requirements into deliverables, gather required information for registration and interact with health authorities and/or the regulatory contacts in different countries.

 

 

Discover our bioMérieux Clinical Affairs and Regulatory Affairs video

 

See our current job openings.