Experteer Overview
In this role, you advance regulatory strategy to secure global approvals for cardiology, endocrinology, women’s health, and critical care IVDs. You’ll anchor regulatory representation in cross-functional, international teams and collaborate across Germany, Switzerland, the US, and Asia to accelerate registrations. You’ll manage EU/US/China submissions, interface with health authorities, and maintain up-to-date product documentation. This position offers global impact within a mission-driven company that values ethics and patient access to diagnostics and medicines. You will work in a matrix, international environment and help shape regulatory excellence across regions.

Compensaciones / Beneficios
• Provide strategic regulatory direction in international, interdisciplinary teams
• Manage registrations for cardiology, endocrinology, women’s health, and critical care products in EU, US, and China




• Prepare and submit premarket submissions to FDA or Notified Bodies; be primary interface to health authorities
• Interact with regulatory agencies to expedite approvals and respond to questions
• Maintain and update technical documentation for the product portfolio
• Collaborate with colleagues across Germany, Switzerland, US, and general Regulatory Affairs teams (China/Japan) to enable efficient approvals

Responsabilidades
• Bachelor’s / Master degree in Life Science, Data Science or related subject
• minimum 5 years of experience in Regulatory, Ru0026D, Quality, Operations or Clinical
• technical understanding of medical devices or IVDs
• knowledge of international laws and regulations for IVDs in EU, US, and China
• experience juggling multiple projects and multitasking
• project management in an agile environment
• excellent knowledge of English; additional language is a plus

Requisitos principales
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📌 Regulatory Affairs Project Manager (m/f/d) (San Cugat del Vallés)
🏢 Roche
📍 San Cugat del Vallés