Manager Technical Study Coordination (f/m/d)

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

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-re...