As a Senior Process Manager within the Design Control Excellence (DCE) team in Sant Cugat, you will be responsible for the essential development processes that ensure our life‑saving products are safe, effective, and compliant. You will play a key role in executing requirements, risk, configuration, defect management, and verification & validation within complex development projects.There are 2 positions of this role.Responsibilities- Lead Process Governance: Provide expert guidance and support for complex system, software, and assay projects across risk, requirements, configuration, and defect management.- Master Requirements & Traceability: Support multi‑level requirements traceability and maintain all data within a streamlined, database‑driven approach across projects.- Conduct Strategic Risk Assessments: Lead detailed product risk assessments by analyzing documents, reports, and market trends alongside cross‑functional teams.- Establish Configuration Management: Build and maintain configuration management for complex projects, ensuring a clear overview of past, present, and future product states.- Ensure Regulatory Excellence: Provide specialized support to ensure that Verification & Validation (V&V)



activities meet internal standards and integral regulatory requirements such as ISO 13485.- Drive Radical Simplification: Proactively identify opportunities for process optimization and simplification to improve time‑to‑market without compromising quality.- Collaborate Globally: Thrive in an agile, multicultural setting where we experiment, learn, and trust each other to deliver the best results for patients.Qualifications- Advanced Academic Foundation: A Master’s degree in Engineering, Life Sciences, Natural Sciences, or a related field.- Experience: Minimum of three years of experience in a regulated environment within product development or process management (Medical Device or Diagnostics industry preferred).- Technical Mastery: A strong understanding of Design Control processes and global standards such as ISO 13485 or IEC 62304.- Digital Fluency: Experience with ALM tools such as Jira, Azure DevOps, or specialized requirements management software is highly valued.- Exceptional Communication: Precise and efficient communication skills in English, enabling effective collaboration across our international sites.Roche is an Equal Opportunity Employer.#J-18808-Ljbffr

📌 Senior Process Manager (Vallés)
🏢 F. Hoffmann-La Roche
📍 Vallés