Job Detail

Referenz-Nr.
65_1993.z60_5

Kontakt
Andreas Zgraggen
+41 (0) 41 445 70 77
andreas.zgraggen@zentra.ch

You wanna take the lead of highly skilled employees and work in an interdisciplinary enviroment with scientists, engineers and lab specialists from various disciplines? For our international partner, Roche Diagnostics International Ltd. based in Rotkreuz, we are looking for a qualified and motivated Project and Study Lead System Verification (m/f/d).

Tätigkeiten

• As a member of our Research & Development department, you will shape the new project team for our new system development, and maintain crucial interfaces to people outside R&D (regulatory affairs, clinical operations)


• You are responsible for testing of system product specifications, e.g. analytical performance, overall system reliability etc. as required by IVDR


• You are responsible for budgeting, tracking and reporting of all activities, and you are the study lead, i.e. ensure detailed planning and execution of the studies as well as evaluation and documentation of results


• You lead a team consisting of trained lab personnel and scientists. Your main interfaces include the program development lead, regulatory affairs, clinical operations, design quality assurance and project controlling


• You will ensure that tests are executed according to international guidelines and internal processes, and you will be responsible for demonstrating substantial equivalence to predicate devices. You are also part of the interdisciplinary team for registration activities with notified bodies

Anforderungen

• Have a background in chemistry, biology, lab medicine or other natural sciences (MSc, PhD or other further education)


• Be experienced in testing, verification and specification of analytical systems comprising chemical assays


• Know the regulatory requirements and guidelines for verification of in-vitro-diagnostic assays


• Preferably, you contributed in the past to regulatory submissions in direct contact with authorities


• Be a people leader and a good communicator at the interfaces and with stakeholders


• Be experienced in planning and coordination of test and verification activities


• You're someone who wants to influence your own development

It is important that you develop your professional skills to be succesful. We offer our employees an annual budget for professional trainings.  

For further information, please contact the responsible consultant Paolo Gulleri. We are looking forward to receiving your complete application, preferably by e-mail (curriculum vitae, job references & diplomas).  

We also accept your application by physical mail, but will not return them for administrative reasons.

Gerne erwarten wir Ihre komplette Bewerbung via Mail (Lebenslauf, Arbeitszeugnisse & Diplome).
Bewerbungen per Post bearbeiten wir gerne, werden aus administrativen Gründen jedoch nicht retourniert.