Experteer Overview In this role you support Ruamp;D Diagnostics by planning, tracking, and preparing product development documentation for design control and regulatory needs.
You work across integral, 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 / Beneficios • 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 RuD documentation • Strong knowledge of quality management systems, ISO *, IVDR and/or MDR /EU • Proficiency in English and German (written and spoken) • 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 •

📌 Milestone & Change Support Senior Specialist (España)
🏢 Roche
📍 España