La position As a Senior Process Manager within our 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 requirement, risk, configuration, defect management and verification & validation within complex development projects.

This is an opportunity to join a growing innovation hub where you will work in a cross‑functional environment to ensure compliant execution while continuously optimizing efficiency to meet evolving organizational needs.

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 ensure all data is maintained 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 both internal standards and integral regulatory requirements like 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.

Who You Are You are a proactive and service‑oriented professional who excels at solving complex problems independently. You bring strong analytical thinking and the ability to communicate precisely in a collaborative, global environment.

To be successful in this role, you bring:

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.

There are 2 positions of this role.

Roche est un employeur offrant l'équité en matière d'emploi.

📌 Senior Process Manager (Madrid)
🏢 Roche Holding
📍 Madrid