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 Integral 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 global 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 a

📌 Regulatory Affairs Project Manager (Madrid)
🏢 Roche
📍 Madrid