Milestone & Change Support Senior Specialist

About the role

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

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.
• Keep the product portfolio at a continuously IVDR-compliant documentation standard.
• Provide resources to support stakeholders on project and product documentation and contribute to improving standards and tools.
• Implement and maintain occupational health and environmental safety regulations, quality management, Roche guidelines, legal and regulatory requirements.

Required profile

• University degree, preferably in a technical, scientific or business discipline, preferably Chemistry, Biology or Pharmaceutical Sciences.
• 5+ years of relevant experience in diagnostic product development, document management and compliant documentation of R&D products.
• Excellent written and spoken English and German.
• Ability to work independently with minimal guidance, coach or mentor juniors and lead initiatives, and to work in intercultural, international teams.
• Occasional multi-day travel to other Roche sites (e.g. Germany, Switzerland) and evening meetings may be required.

Required skills

• Knowledge of quality management systems, ISO 13485, IVDR and/or MDR 2017/745/EU.
• Practical experience with post-market surveillance and vigilance and product change management.
• Proficiency in common office applications and document management systems.