Senior Milestone & Change Lead - IVDR Docs

Roche Holding AG; Sant Cugat del Vallès; Vor Ort; EUR 70.000 - 95.000; Vollzeit

Zusammenfassung

Roche Holding AG seeks a Milestone & Change Support Senior Specialist to advise and support the R&D Diagnostics units in planning, tracking, and preparing product development documentation for design control and regulatory needs.

You will work in a cross-functional, multi-location team, coordinating with internal stakeholders to optimize processes and support offerings while ensuring IVDR-compliant documentation.

Qualifikationen

• University degree in a technical, scientific or business discipline (Chemistry, Biology or Pharmaceutical sciences preferred).
• 5+ years of relevant professional experience in diagnostic product development, document management, and compliant documentation of R&D products.
• Excellent written and verbal English and German language skills.

Aufgaben

• Proactive creation, implementation, monitoring and improvement of quality of product documentation under quality management standards.
• Aim to achieve project milestones without corrective actions and IVDR-compliant recertification of products.
• Contribute to keeping the product portfolio IVDR-compliant in documentation.
• Provide resources to support stakeholders regarding project/product documentation; contribute to development of standards and tools.
• Implement and maintain applicable regulations on occupational health, environment safety, quality management, Roche guidelines, and regulatory demands.

Kenntnisse

English language proficiency

German language proficiency

Interdisciplinary thinking

Negotiation skills

Ausbildung

University degree in technical/scientific/business

Tools

Microsoft Office

Document management systems

Jobbeschreibung

Roche Holding AG seeks a Milestone & Change Support Senior Specialist to advise and support the R&D Diagnostics units in planning, tracking, and preparing product development documentation for design control and regulatory needs.

You will work in a cross-functional, multi-location team, coordinating with internal stakeholders to optimize processes and support offerings while ensuring IVDR-compliant documentation.