At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
At Global Regulatory Affairs our aspiration is to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Focus of our work is the global approval of in-vitro-diagnostics of the Elecsys Core reagent immunoassay product portfolio. Our dynamic team manages regulatory projects as well as overarching regulatory topics. Join an open-minded work environment where close collaboration with colleagues across various departments and countries is not just encouraged, but essential.
The Opportunity

Shape Strategic Direction:



You will steer the strategic direction and represent the Regulatory Affairs department in international, interdisciplinary teams to foster an effective and successful working environment
Manage Global Product Registrations: You will manage product registrations across Europe, the United States, and China, while supporting broader worldwide registration efforts
Act as a Key Interface: You will prepare and submit pre-market applications to the FDA or Notified Bodies, serving as the primary liaison to general health authorities
Drive Authority Interaction: You will actively interact with regulatory bodies to accelerate approvals or clearances for upcoming registrations and professionally address inquiries of all kinds
Ensure Portfolio Excellence: You will support product maintenance activities and continuously keep the technical documentation of our product portfolio up to date
Leverage International Synergies: To achieve efficient global approval

📌 Regulatory Affairs Project Manager (San Cugat del Vallés)
🏢 Roche
📍 San Cugat del Vallés