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

📌 Regulatory Submission Expert - Remote (Montreal)
🏢 MIRA
📍 Montreal