Experteer Overview In this high-impact role, you drive global regulatory strategies for the Elecsys immunoassay portfolio, focusing on cardiometabolic and neurology indications. You will lead cross-functional teams across regions to accelerate approvals and ensure regulatory compliance. As the primary interface with integral health authorities, you shape submissions and strategic directions to enable patient access to cutting-edge diagnostics. You thrive in a collaborative, international environment and help optimize time-to-market while maintaining high compliance standards. This role offers meaningful impact by advancing diagnostic capabilities across the globe.Compensaciones / Beneficios
- Lead global regulatory strategies for Elecsys immunoassay portfolio with emphasis on cardiology and neurology.
- Represent Regulatory Affairs in international, cross-functional project teams to foster collaboration.
- Manage end-to-end product registrations for high-burden reagents in the US, Europe, and China and support worldwide regulatory processes.
- Serve as primary interface with global health authorities (FDA, Notified Bodies) for submissions,



clearances, and responses.
- Provide regulatory guidance on strategic and tactical objectives to cross-functional stakeholders and business areas.
- Maintain product care activities and ensure technical documentation complies with evolving global regulations.
- Collaborate across global chapters and teams to optimize time-to-market and ensure international compliance.
- Build and maintain relationships across diverse regions (Germany, Switzerland, US, China, Japan).Responsabilidades
- University degree in Life Sciences, Data Science, or related field with substantial regulatory experience (5–8 years, depending on degree).
- In-depth knowledge of international regulatory frameworks for IVDs/medical devices (EU IVDR, FDA, NMPA).
- Experience with immunoassay technologies and managing complex indications (cardiac/neurology).
- Proven track record of direct collaboration with regulatory authorities to obtain product approvals.Requisitos principales
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📌 Regulatory Affairs Manager – Cardiac & Neurology (Barcelona)
🏢 Roche
📍 Barcelona