Header image Universitätsmedizin Göttingen

The University Medical Center Göttingen (UMG) unites the Medical Faculty of Georg-August University and the University Hospital in an integration model. With over 9,700 employees, the UMG and its subsidiaries are one of the largest employers in the region. More than 60 clinics, institutes and departments stand for high-quality patient care, excellent research and modern teaching.

Göttingen as a city of science is located in the center of Germany and the University Medical Center Göttingen is integrated into an attractive network of university and non-university scientific institutions.

The Else Kröner Fresenius Zentrum für optogenetische Therapien of the University Medical Centre Göttingen is looking for a new position for the earliest start date

Regulatory Affairs Manager (f/m/d)

part time, full time , limited until 31.03.2029
Remuneration according to TV-L

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

Our goal as University Medical Center Göttingen is professional equality for all genders. We strive to equalize the gender ratio in areas where there is underrepresentation. The University Medical Center Göttingen is particularly committed to the professional participation of severely disabled people and therefore welcomes applications from severely disabled people. In the case of equal suitability, applications from severely disabled persons will be given preferential consideration in accordance with the relevant regulations. We kindly ask you to indicate a disability/equal status in your letter of application in order to safeguard your interests.

Universitätsmedizin Göttingen
Else Kröner Fresenius Zentrum für optogenetische Therapien
Prof. Dr. Tobias Moser

Robert-Koch-Straße 40
37075 Göttingen

https://ekfz.uni-goettingen.de/

Apply now

Full-Time / Part-Time , Temporary

Specialist

Updated at 03/06/2025

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