Overview
In this role you drive regulatory activities for Roche's Oncology In-vitro Diagnostics team, preparing global submissions and guiding dossiers through health authority processes. You collaborate with internal and external stakeholders to shape regulatory strategies and ensure compliant market access. You'll apply agile methods to manage projects and continuously improve regulatory outcomes. This is an opportunity to impact patient access to innovative diagnostics while working in a diverse, inclusive environment. You help build strong partnerships and influence product direction with integrity and curiosity.
Responsabilidades Oversee development of registration dossiers for moderately complex products and manage global submission plans
Lead external interface efforts, building relationships with stakeholders to influence regulatory direction




Develop regulatory strategies aligned with frameworks like IVDR for simple-to-moderate complexity products
Manage stakeholder relationships and communicate requirements and updates clearly
Identify issues and propose solutions, driving innovation within the role
Promote VAAC leadership principles and contribute to an inclusive, agile work environment
Foster teamwork, share knowledge, and participate in conflict resolution
Requisitos principales Bachelor's in Life Science (equivalent experience considered)
1+ years in Regulatory, R&D;, Quality and/or Clinical
Experience in Healthcare Regulatory Affairs for IVD/Medical Device preferred
Ability to manage high-complexity work and integral projects
collaboration
stakeholder management
clear communication
regulatory submissions
regulatory knowledge of IVDR
project management

📌 Regulatory Affairs Specialist (Barcelona)
🏢 Roche
📍 Barcelona