Milestone & Change Lead: R&D Documentation & Compliance

Roche; Sant Cugat del Vallès; On-site; EUR 60,000 - 80,000; Full time

Job summary

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

You will collaborate with cross-functional teams globally to optimize processes and ensure IVDR-compliant documentation while supporting stakeholders with resources and tools. Expect occasional travel to Roche sites.

Qualifications

• Bachelor’s or equivalent degree in a technical, scientific, or business discipline.
• 3+ years of relevant diagnostic product development, document management, and R&D documentation experience.
• Excellent written and verbal English and German language skills are required.
• Knowledge of quality management systems (ISO 13485) and IVDR/MDR is a plus.

Responsibilities

• Proactively create, implement, monitor, and improve quality of product documentation per quality standards.
• Drive milestones with no corrective actions and support IVDR-compliant recertification.
• Maintain IVDR-compliant documentation standards for the product portfolio.
• Provide resources to stakeholders for project/documentation needs and contribute to standards/tools development.
• Implement and maintain regulations on health, safety, quality, Roche guidelines, and regulatory demands.

Skills

Interdisciplinary thinking

Self-organization

Teamwork

Negotiation skills

Education

University degree

Job description

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

You will collaborate with cross-functional teams globally to optimize processes and ensure IVDR-compliant documentation while supporting stakeholders with resources and tools. Expect occasional travel to Roche sites.