Milestone & Change Support Senior Specialist

En Roche puedes ser tú mismo y sentirte valorado por tus cualidades únicas. Nuestra cultura fomenta la expresión personal, el diálogo abierto y las conexiones genuinas, donde eres valorado, aceptado y respetado por lo que eres, permitiéndote prosperar tanto de manera personal como profesionalmente. Así es como buscamos prevenir, detener y curar enfermedades y asegurarnos de que todos tengan acceso a la atención sanitaria hoy y para las futuras generaciones. Únete a Roche, donde cada voz importa. La posición Who We Are At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. What Awaits You: In this exciting and challenging position as Milestone & Change Support Senior Specialist, you will play a key role in advising and supporting the R&D units of Diagnostics in the planning, tracking, and preparation of product development documentation for design control and regulatory requirements. You work in a cross-functional team distributed across multiple locations involved in global product development projects. Furthermore, you will be in continuous exchange with our internal stakeholders across multiple functions to optimize processes and support offerings. Your Team The Milestone & Change Support Team is part of a global team in R&D that focuses on internal improvement: increasing productivity, efficiency, and the ability of the R&D organization to collaborate across its global organizational interfaces. Perfection is our passion, and relieving the workload of R&D units while boosting our customers' effectiveness and efficiency is our mission. Excellence and customer orientation define our identity. We support each other unconditionally, but we are also not afraid to handle tasks independently and proactively. Through our high focus, we accelerate and optimize internal processes, easing the burden on the organization. Your Responsibilities: - You share responsibility for the proactive creation, implementation, monitoring, and improvement of quality of product documentation under the quality management standards. - Your goal is to achieve project milestones without corrective actions and to ensure IVDR-compliant recertification of our products - You make a decisive contribution to keeping our product portfolio at a continuously IVDR-compliant documentation standard - You share responsibility for providing all types of resources to actively support stakeholders regarding project/product documentation, actively contributing to the continuous development of our standards and tools - You are responsible for implementing and maintaining applicable regulations on occupational health and environmental safety, quality management, Roche guidelines, legal requirements, and regulatory demands Who You Are: - Education: University degree, preferably in a technical, scientific, or business discipline - preferably in Chemistry, Biology, or Pharmaceutical sciences - Experience: 5+ years of relevant professional experience in diagnostic product development, document management, and compliant documentation of R&D products. - Language Skills: Excellent written and verbal English AND German Language skills are required - You should have comprehensive knowledge of quality management systems, ISO 13485, IVDR, and/or MDR 2017/745/EU, as well as practical experience with post-market surveillance and vigilance processes and product change management - You are confident and proficient in using common office applications and document management systems - A high level of service orientation and customer focus come naturally to you, as do utmost care and reliability - Interdisciplinary thinking and strong negotiation skills are among your strengths - You possess strong self-organizational skills, are willing to work independently with minimal guidance, and like to drive things forward proactively. As a senior specialist, you may be asked to coach or mentor more junior employees or lead initiatives. - A confident demeanor, excellent communication skills, and the ability to build a shared understanding set you apart - You have a strong drive and ability for teamwork and thoroughly enjoy working with intercultural and international teams - Occasional multi-day travel to other Roche sites (e.g. Germany, Switzerland) may be required. To support the global nature of our work (e.g. collaboration between the US and Europe), customer and stakeholder meetings periodically require participation in meetings during the early evening hours (e.g. 1900) Quienes somos Alcanzar un futuro más saludable es lo que nos impulsa a innovar. Juntos, más de 100.000 empleados en todo el mundo están dedicados a avanzar en la ciencia, asegurando que todos tengan acceso a la atención sanitaria hoy y para las futuras generaciones. Nuestros esfuerzos resultan en más de 26 millones de personas tratadas con nuestros medicamentos y más de 30 mil millones de pruebas realizadas con nuestros productos de Diagnósticos. Nos damos apoyo mutuamente para explorar nuevas posibilidades, fomentar la creatividad y mantener altas nuestras ambiciones, para poder ofrecer soluciones sanitarias que cambian la vida e impactan a nivel global. Construyamos juntos un futuro más saludable. Roche es una empresa que ofrece igualdad de oportunidades.