Senior Milestone & Change Lead – R&D Documentation

F. Hoffmann-La Roche AG; Sant Cugat del Vallès; On-site; EUR 70,000 - 95,000; Full time

Job summary

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

You will collaborate across global product development projects, driving IVDR-compliant documentation and process improvements while supporting stakeholders with resources and standards development.

Qualifications

• University degree in a technical, scientific, or business discipline.
• 5+ years of professional experience in diagnostic product development and compliant documentation of R&D products.
• Excellent written and verbal English AND German language skills.
• Strong knowledge of ISO 13485, IVDR, and MDR 2017/745/EU, and post-market surveillance.
• Willingness to coach or mentor junior employees and lead initiatives.

Responsibilities

• Proactively create, implement, monitor, and improve product documentation under quality management standards.
• Ensure IVDR-compliant recertification of our products.
• Maintain IVDR documentation to keep the portfolio at a high standard.
• Provide resources to support stakeholders regarding project/product documentation.
• Implement and maintain applicable regulations on health, safety, quality, Roche guidelines, and regulatory demands.

Skills

Quality management

IVDR/MDR knowledge

Regulatory documentation

Cross-functional teamwork

English & German proficiency

Education

University degree in Chemistry/Biology/Pharma

Tools

Office applications

Document management systems

Job description

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

You will collaborate across global product development projects, driving IVDR-compliant documentation and process improvements while supporting stakeholders with resources and standards development.