Milestone & Change Support Specialist

About the role

Roche is looking for a Milestone & Change Support Specialist in Sant Cugat del Vallès to advise and support the R&D units of Diagnostics in planning, tracking and preparing product development documentation for design control and regulatory requirements. You will work in a cross-functional team spread across several locations on global product development projects, in close contact with internal stakeholders.

Key responsibilities

• Create, implement, monitor and improve the quality of product documentation under quality management standards, aiming to reach project milestones without corrective actions and to ensure IVDR-compliant recertification of products.
• Keep the product portfolio at a continuously IVDR-compliant documentation standard.
• Provide resources to support stakeholders on project and product documentation and contribute to the continuous development of standards and tools.
• Implement and maintain occupational health and environmental safety regulations, quality management, Roche guidelines, legal requirements and regulatory demands.

Required profile

• University degree, preferably in a technical, scientific or business discipline, preferably Chemistry, Biology or Pharmaceutical Sciences.
• More than 3 years of relevant experience in diagnostic product development, document management and compliant documentation of R&D products.
• Excellent written and spoken English and German; knowledge of quality management systems, ISO 13485, IVDR and/or MDR 2017/745/EU, and experience with post-market surveillance, vigilance and product change management is preferred.
• Confident with common office applications and document management systems.
• Willingness to travel occasionally to other Roche sites (e.g. Germany, Switzerland) and to attend early evening meetings.