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In this role you support Ru0026amp;D Diagnostics by planning, tracking, and preparing product development documentation for design control and regulatory needs. You work across global, cross-functional teams to optimize processes and ensure IVDR/MDR-aligned documentation. You help maintain a high-quality documentation standard while driving continuous improvements. You will interact with multiple stakeholders, coach junior staff, and may lead initiatives in a globally distributed environment.
Compensaciones / Ventajas
• Co-create and manage quality product documentation under applicable quality management standards
• Pursue milestone-driven delivery with IVDR-compliant recertification of products
• Contribute to maintaining continuous IVDR-compliant documentation across the product portfolio
• Provide resources and support for project/documentation needs and help develop standards/tools
• Implement and maintain regulations on occupational health, environmental safety, quality management, Roche guidelines, and regulatory demands
Responsabilidades
• 5+ years of relevant experience in diagnostic product development and compliant Ru0026D documentation
• Strong knowledge of quality management systems, ISO 13485, IVDR and/or MDR 2017/745/EU
• Proficiency in English and German (written and spoken) xghoner
• Experience with post-market surveillance, vigilance, and product change management
• Proficient in common office applications and document management systems
• High service orientation, reliability, and cross-functional collaboration skills
• Strong self-organization, independence, and proactive driving of initiatives
• Experience coaching or mentoring and leading initiatives as a senior specialist
Requisitos principales
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📌 Milestone & Change Support Senior Specialist (San Cugat del Vallés)
🏢 Roche
📍 San Cugat del Vallés
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