Milestone & Change Support Senior Specialist

Roche Holding AG; Sant Cugat del Vallès; Presencial; EUR 70.000 - 95.000; Jornada completa

Descripción de la vacante

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

You will work in a cross-functional, multi-location team, coordinating with internal stakeholders to optimize processes and support offerings while ensuring IVDR-compliant documentation.

Formación

• University degree in a technical, scientific or business discipline (Chemistry, Biology or Pharmaceutical sciences preferred).
• 5+ years of relevant professional experience in diagnostic product development, document management, and compliant documentation of R&D products.
• Excellent written and verbal English and German language skills.

Responsabilidades

• Proactive creation, implementation, monitoring and improvement of quality of product documentation under quality management standards.
• Aim to achieve project milestones without corrective actions and IVDR-compliant recertification of products.
• Contribute to keeping the product portfolio IVDR-compliant in documentation.
• Provide resources to support stakeholders regarding project/product documentation; contribute to development of standards and tools.
• Implement and maintain applicable regulations on occupational health, environment safety, quality management, Roche guidelines, and regulatory demands.

Conocimientos

English language proficiency

German language proficiency

Interdisciplinary thinking

Negotiation skills

Educación

University degree in technical/scientific/business

Herramientas

Microsoft Office

Document management systems

Descripción del empleo

Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.

La 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)

Qui nous sommes

Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.

Construisons ensemble un avenir plus sain.

Roche est un employeur offrant l'équité en matière d'emploi.