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The PositionYour impact

As a Technical Study Coordination expert (m/f/d) in the Research & Development area, you will support our organization with broad specialist knowledge at the interface between the development and clinical testing of medical devices. Your ability to abstract and your profound understanding of the development process and approval processes enable you to plan and control technical documentation adapted to different stages of development.

As part of our team, your responsibilities include, among others, the following activities:

Contributing to developing a project-specific strategy for planning, implementing and setting the objectives of studies

Supervising and supporting the creation of high-quality and useful development-related and submission-relevant documentation

Identifying questions relevant to (study) admissions and mediating between various stakeholders

Designing the practical and pragmatic application of relevant regulations and standards in the area of ​​technical documentation required for university admissions

Guiding members of cross-functional teams on these topics

Mapping requirements into requirements documents yourself or support others in doing so

Looking for potential for improvement in established processes and trying to implement this on a case-specific basis

Who you are

You have completed your bachelor's or master's degree in the natural sciences and technology, ideally with a suitable specialization (medical device technology).

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

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

You have successfully supported development-related studies from the development side, while maintaining direct and indirect exchanges with partners relevant to clinical studies, such as regulatory authorities, notified bodies and ethics committees.

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, your willingness to make decisions and your organizational talent, you are able to quickly analyze and solve challenges.

You communicate fluently in English and German in a technical and regulatory environment.

Your contact to us! With people. For people.

Do you need further support?

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

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Our success is based on innovation, curiosity and diversity - and on the fact that we regard our variety as a benefit. With 40 years of experience in the diabetes business, Roche Diabetes Care is the market leader and a driver and shaper of the future of care for people with diabetes. Digitisation is an essential element of our work.

Roche is an Equal Opportunity Employer.