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
- 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
Vacancy posted 16 hours ago
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