Milestone & Change Support Senior Specialist

F. Hoffmann-La Roche AG; Sant Cugat del Vallès; Presencial; EUR 70 000 - 95 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Quality management

IVDR/MDR knowledge

Regulatory documentation

Cross-functional teamwork

English & German proficiency

Formação académica

University degree in Chemistry/Biology/Pharma

Ferramentas

Office applications

Document management systems

Descrição da oferta de emprego

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position 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).

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.