Student Assistant – IT Support for Regulatory Affairs | Student Assistant (w/m/d) – IT Support for Regulatory Affairs

Job Summary

This role seeks a highly motivated Student Assistant to provide essential IT support within the Regulatory Affairs team at the Else Kröner Fresenius Center for Optogenetic Therapies (EKFZ OT). The successful candidate will be crucial in supporting the design, implementation, and maintenance of regulatory compliant digital Quality Management Systems (QMS), adhering to standards like 21 CFR-Part 11/820 and DIN EN ISO 13485. Day-to-day tasks involve implementing IT systems in a regulated GxP environment, developing comprehensive lifecycle documentation, creating and executing test protocols, and ensuring technical documentation supports system security and compliance. You will also manage databases and support accurate reporting, collaborating closely with EKFZ teams and external service providers. The ideal candidate is an enrolled student in a relevant technical field (e.g., Computer Science or Medical Informatics), possesses strong organizational skills, and is fluent in written and oral English. This position offers the chance to work in an inspiring, international research environment focused on innovative translational therapies for conditions like deafness and blindness, with the prospect of longer-term employment and mentorship.