Remote Regulatory Submissions Specialist — EU IVDR/CE

Mira; Lombardia; A distancia; EUR 81.000 - 116.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work

Competitive salary

OKR-based bonus system

Career growth opportunities

Descripción de la vacante

Mira, a fast-growing femtech company, seeks a Regulatory Submission Specialist to lead and support regulatory documentation for in vitro diagnostic devices. You will ensure compliance across technical documentation and regulatory programs while collaborating with internal teams and external consultants.

The role emphasizes EU IVDR CE-marking readiness, post-market surveillance, and cross-functional coordination in a remote, fast-paced startup environment that serves a global market.

Formación

• Bachelor’s degree in Regulatory Affairs or closely related field.
• 2+ years of regulatory affairs experience for medical devices or IVDs.
• Experience with EU IVDR CE-marking requirements and post-market surveillance.

Responsabilidades

• Prepare and maintain IVD regulatory submission dossiers and technical documentation.
• Review intended-use statements, labeling, and product claims for regulatory alignment.
• Assess analytical, clinical-performance, usability, and risk-management evidence.
• Coordinate evidence collection from internal teams, labs, and external consultants.
• Develop regulatory evidence plans and studies (analytical/clinical).
• Prepare responses to regulatory authority questions and audit docs.
• Maintain regulatory intelligence on IVD regulations and standards.
• Support post-market activities and lifecycle regulatory updates.

Conocimientos

Regulatory submissions

Technical writing

Stakeholder coordination

Project management

Educación

Bachelor's degree in Regulatory Affairs

Descripción del empleo

Mira, a fast-growing femtech company, seeks a Regulatory Submission Specialist to lead and support regulatory documentation for in vitro diagnostic devices. You will ensure compliance across technical documentation and regulatory programs while collaborating with internal teams and external consultants.

The role emphasizes EU IVDR CE-marking readiness, post-market surveillance, and cross-functional coordination in a remote, fast-paced startup environment that serves a global market.