Manager Technical Study Coordination (fmd)

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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 Bachelors or Masters 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!

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Roche is an Equal Opportunity Employer.

Required Experience :

Manager

Key Skills

Shipping & Receiving,Microsoft Office,Customer Service,Freight Experience,Transportation Management Systems,EDI,Microsoft Outlook,Supply Chain Experience,Dispatching,Microsoft Excel,Logistics,3PL

Employment Type : Full-Time

Experience : years

Vacancy : 1