The Institute for Auditory Neuroscience of the University Medical Center Göttingen (Germany) invites applications for a

Quality- & Regulatory
Affairs Manager (f/m/d)

for development of a regulatory
strategy for a gene therapy / active
implant combination product

initially limited until 31.12.2023, full time | salary
according to TV-L

The University Medical Center Göttingen is a tertiary care center and offers great development potential. Its 7,900 employees work in over 65 departments and facilities to provide top-quality patient care, excellent research and modern teaching. Göttingen, “City of Science”, located near the center of Germany, the University Medical Center Göttingen is embedded in the city’s attractive network of scientific research facilities. The optical cochlear implant project at the Institute for Auditory Neuroscience in collaboration with OptoGenTech GmbH develops a novel medical device (class III) in combination with a gene therapy medicinal product to restore natural hearing in deaf patients. Your tasks:

• development of a regulatory strategy for a combination product
• preparation of the documentation for active medical implants (ISO 13485)
• regulatory preparation of gene therapy medicinal product manufacturing
• coordination of regulatory affairs projects in compliance with deadlines and timelines

Your profile:

• 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)
• experience with ISO 13485 regulations is of advantage
• ability to work in a team, flexibility, assertiveness, and independent action
• good understanding of technology and complex interrelationshipsg
• good knowledge of English and German

We offer:

• possibility to lead a revolutionizing technology for hearing impaired people into the clinics
• work in an interdisciplinary and dynamic team
• being part of the Göttingen Campus as a leading Neuroscience Center hosting numerous prestigious and internationally renowned research institutions including the University and its Medical Center, the largest Max Planck Institute, the European Neuroscience Institute, and the German Primate Center

The University Medical Center Göttingen is committed to professional equality. We therefore seek to increase the proportion of under-represented genders. Applicants with disabilities and equal qualifications will be given preferential treatment. We look forward to receiving your application by June 15th, 2022: University Medical Center Göttingen
Institute for Auditory Neuroscience
Tobias Moser
Director
D-37099 Göttingen
Tel.: +49 (0) 551/39-63071
E-Mail: ianoff@gwdg.de
Web: https://www.auditory-neuroscience.uni-goettingen.de/