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
for German version please see below –
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 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
In this high-impact strategic role,



you will champion patient access to cutting-edge diagnostic solutions by leading global regulatory strategies for our Elecsys immunoassay portfolio, specifically focusing on complex cardiometabolic and neurology product lines.
Provide global strategic regulatory direction and represent Regulatory Affairs within international, cross-functional project teams to build a highly collaborative and fruitful work environment
Drive and manage end-to-end product registrations for high-burden cardiology and neurology reagents in the United States, Europe, and China, while steering supporting registration frameworks worldwide
Act as the primary interface and lead communication with general health authorities, including the FDA and European Notified Bodies, to expedite premarket submissions, clearances, and responses
Deliver clear, proactive regulatory guidance on strategic and tactical objectives to cross-functional stakeho

📌 Regulatory Affairs Manager (España)
🏢 Roche
📍 España