EU IVDR/CE Regulatory Submissions Specialist

Mira; Amsterdam; Remote; EUR 70.000 - 95.000; Vollzeit

Benefits dieser Stelle

Fully remote

Competitive salary

Bonus program

Career growth

International team

Zusammenfassung

Mira, a San Francisco-based hormonal health company, seeks a Regulatory Submission Specialist to lead submission documentation for in vitro diagnostic devices. This remote role supports regulatory compliance across the product lifecycle and involves collaboration with global teams.

The ideal candidate brings EU IVDR CE-marking experience, strong technical writing, and the ability to coordinate cross-functional evidence across analytical, clinical, usability, and risk domains.

Qualifikationen

• 2+ years of regulatory affairs for medical devices or IVDs
• Experience preparing CE marking under EU IVDR
• Working knowledge of ISO 13485, ISO 14971, ISO 20916 and post-market requirements
• Experience reviewing analytical-performance and clinical-performance documentation for IVDs

Aufgaben

• Prepare and maintain IVD regulatory submission dossiers and related documentation
• Review intended-use statements, product claims, instructions for use, labelling and materials for regulatory alignment
• Assess analytical, clinical-performance, usability, stability, software and risk-management evidence
• Coordinate evidence collection with internal teams, manufacturers, clinical research organisations, laboratories, quality teams and consultants
• Identify evidence gaps and develop regulatory evidence plans including studies
• Support preparation and review of clinical-performance documents and evaluations
• Prepare responses to regulatory authority questions and audit documentation
• Maintain regulatory intelligence on IVD regulations, standards, and market requirements
• Support post-market regulatory activities and changes
• Partner with Quality, R&D, Clinical, Product and Commercial teams for lifecycle compliance

Kenntnisse

Regulatory writing

Project management

Stakeholder coordination

Independent startup environment

Ausbildung

Bachelor's degree in Regulatory Affairs or Life Sciences

Jobbeschreibung

Mira, a San Francisco-based hormonal health company, seeks a Regulatory Submission Specialist to lead submission documentation for in vitro diagnostic devices. This remote role supports regulatory compliance across the product lifecycle and involves collaboration with global teams.

The ideal candidate brings EU IVDR CE-marking experience, strong technical writing, and the ability to coordinate cross-functional evidence across analytical, clinical, usability, and risk domains.