Milestone & Change Support Specialist

Roche; Sant Cugat del Vallès; On-site; EUR 60,000 - 80,000; Full time

Job summary

Roche seeks a Milestone & Change Support Specialist to advise and support R&D Diagnostics in planning, tracking and preparing product development documentation for design control and regulatory needs.

You will collaborate with cross-functional teams globally to optimize processes and ensure IVDR-compliant documentation while supporting stakeholders with resources and tools. Expect occasional travel to Roche sites.

Qualifications

• Bachelor’s or equivalent degree in a technical, scientific, or business discipline.
• 3+ years of relevant diagnostic product development, document management, and R&D documentation experience.
• Excellent written and verbal English and German language skills are required.
• Knowledge of quality management systems (ISO 13485) and IVDR/MDR is a plus.

Responsibilities

• Proactively create, implement, monitor, and improve quality of product documentation per quality standards.
• Drive milestones with no corrective actions and support IVDR-compliant recertification.
• Maintain IVDR-compliant documentation standards for the product portfolio.
• Provide resources to stakeholders for project/documentation needs and contribute to standards/tools development.
• Implement and maintain regulations on health, safety, quality, Roche guidelines, and regulatory demands.

Skills

Interdisciplinary thinking

Self-organization

Teamwork

Negotiation skills

Education

University degree

Job description

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 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: 3+ 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
• Preferred candidates have 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.
• 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.