Regulatory Submission Expert - Remote

Elevate women's health as a Regulatory Submission Specialist at Mira. Bring your expertise in regulatory documentation and EU IVDR compliance to this impactful remote role.
Mira, a leading femtech company in San Francisco, is seeking a Regulatory Submission Specialist. This remote position requires a candidate with 2+ years of experience in regulatory affairs for IVDs, focusing on CE-marking documentation. You will collaborate with teams across the organization to compile and review technical documentation, ensuring alignment with international regulations.
Key Responsibilities: - Prepare IVD regulatory submission dossiers and technical documents - Review product claims and instructions for regulatory compliance - Coordinate evidence collection from various teams and consultants - Identify gaps and develop regulatory evidence plans - Prepare responses to regulatory authority inquiries
Requirements: - Bachelor’s degree in a relevant field - 2+ years of regulatory experience with IVDs - Knowledge of CE-marking under EU IVDR - Experience in analytical and clinical-performance documentation - Excellent technical writing and project-management skills
Join Mira to support compliance and innovation in hormonal health.#J-18808-Ljbffr