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 (Toronto)
🏢 MIRA
📍 Toronto