Regulatory Affairs Manager (m/w/d)
The Else Kröner Fresenius Center for Optogenetic Therapies invite applications for a
initially limited until 03/2029 with the possibility of extension, salary according to TV-L, part time
The EKFZ at the University Medical Center Göttingen is dedicated to the translation of the four core optogenetic approaches to restore i) hearing and ii) vision and explore the potential of optogenetics for iii) gastric pacemaking and iv) brain-computer interfaces. These four teams are supported by the platforms for 1) opsin engineering, 2) gene transfer, 3) disease models, 4) immune-phenotyping and 5) development of medical devices.
The EKFZ relies on a close interdisciplinary collaboration between the University Medical Center Göttingen, the faculties of Physics, Mathematics, and Biology of the University, and non-university research institutions in Göttingen, such as the German Primate Center and the Max Planck Institutes for Multidisciplinary Sciences and for Dynamics and Self-Organization, as well as partners at the Medical University Hannover (MHH) and University of Freiburg.
Your tasks
- Development of a regulatory strategy for a combination product
- Implementation of the requirements of the (EU) 2017/745 Medical Device Regulation (MDR)
- Preparation of the documentation for active medical devices of risk class III
- Preparation of gene therapy medicinal product manufacturing
- Close cooperation with strategic management and development team
- Coordination of regulatory affairs projects in compliance with deadlines and timelines
- Steering and monitoring of structures and frameworks for quality management documents and records as well as their updates
Your qualifications
- Completed scientific studies or technical professional qualification-
- Experience in either the field of biotechnology or medical technology and the relevant and applicable regulations (both is a plus)
- Ability to work in a team, flexibility, assertiveness, and independent action
- Good understanding of technology and complex interrelationships
- Good knowledge of English and German
We offer
- a stimulating intellectual environment with innovative translational research-projects within the interdisciplinary research areas
- integration into a well-experience coordination team
- a wide range of interesting benefits as an UMG employee (including in-house daycare center, child vacation care, attractive infrastructure; health and sports promoted by excellent company health management)
- location in a beautiful and historic German university town steeped in tradition, with a campus that includes the University of Göttingen, Max Planck Institutes, German Primate Centre and other local research institutions