Regulatory Submission Expert - Remote

Mira

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

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Vacancy posted 12 hours ago

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