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Regulatory Affairs Director — Global Submissions & Strategy

HepQuant, LLC, Denver, CO, United States


A clinical laboratory is seeking a Regulatory Affairs specialist in Denver, Colorado, with at least 8 years of experience. The role involves preparing documents for regulatory submissions, engaging with FDA and cross-functional teams, and reviewing promotional materials. Ideal candidates should have strong analytical and communication skills, and experience with FDA/EU submissions is essential. RAC Certification is preferred. Join to contribute to innovative blood-based tests that support clinical management. #J-18808-Ljbffr