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The Position

Shape the future with us – as a Manager Technical Study Coordination (m/f/d)

In the Research & Development department, as a Manager Technical Study Coordination (f/m/d) , you will support our organization with your broad expertise at the interface between the development and clinical testing of medical devices. Your ability to think abstractly and your profound understanding of the development and approval processes enable you to plan and manage technical documentation adapted to different development stages.

Your Tasks

As part of our team, your responsibilities will include the following:

• You contribute to developing a project-specific strategy for the planning, execution, and objectives of studies.

• You oversee and support the creation of high-quality, fit-for-purpose documentation that accompanies development and is relevant for submissions.

• You identify (study) approval-relevant questions and mediate between various stakeholders.

• You shape the practical and pragmatic application of relevant regulations and standards in the area of technical documentation necessary for study approvals.

• You coordinate the collaboration of cross-functional teams on these topics.

• You either define requirements in specification documents yourself or support others in doing so.

• You look for potential for improvement in established processes and try to implement it on a case-by-case basis.

What you bring to the table

• You have successfully completed your Bachelor's or Master's degree in a scientific or technical field, ideally with a relevant specialization (medical device technology).

• Your several years of professional experience enable you to work independently in an international environment.

• You have experience in the interpretation and practical implementation of regulations and standards relevant to medical device development, preferably the MDR/IVDR.

• You have expertise in the development and approval of medical devices across several functional areas (documentation, risk management, quality engineering, regulatory affairs, etc.).

• You have successfully supported development-accompanying studies from the development side.

• You enjoy direct and indirect exchange with partners relevant to clinical studies, such as regulatory authorities, notified bodies, and ethics committees.

• You successfully moderate cross-functional teams and achieve consensual decisions even on complex issues with far-reaching consequences.

• You are known for your passion for independently exploring new approaches and topics and not letting potential setbacks throw you off course.

• Strategic and creative thinking are the basis for your excellent understanding of the needs of internal interfaces and your strong business acumen.

• Thanks to your excellent communication skills, decisiveness, and organizational talent, you can quickly analyze and solve challenges.

• You are fluent in English and German for negotiations in a technical-regulatory environment.

The advertised position is also suitable for part-time work.

Your Application

Please upload only your current and informative curriculum vitae as well as your certificate/diploma of your highest academic degree.

We look forward to receiving your application!

Your contact to us! With people. For people.

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Please have a look at our FAQs, you will find them via https://careers.roche.com/global/en/faq .

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.