Quality Control and Regulatory Affairs Manager (f/m/d)

Universitätsmedizin Göttingen; Deutschland; Vor Ort; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A renowned medical research institution in Germany is seeking a professional to implement and manage a digital quality management system for optogenetic therapies. Responsibilities include developing regulatory strategies, ensuring compliance with medical regulations, and collaborating closely with various teams. Requires a scientific degree or technical qualification, expertise in regulatory affairs, and good knowledge of English and German. Join us for innovative research in a historic university town.

Leistungen

In-house daycare center

Child vacation care

Company health management

Attractive infrastructure

Qualifikationen

• Experience in biotechnology or medical technology.
• Proven expertise in regulatory affairs and quality management.

Aufgaben

• Implement and manage a digital quality management system.
• Develop a regulatory strategy for optogenetic therapies.
• Collaborate closely with regulatory consultants and authorities to ensure compliance.

Kenntnisse

Team player

Flexibility

Assertiveness

Good technical understanding

Ability to analyze complex systems

Knowledge of English and German

Ausbildung

Completed scientific degree or technical professional qualification

Tools

Experience with regulatory frameworks

Jobbeschreibung

full time, part time , initially limited until 31.12.2026 with the option of extension
Remuneration according to TV-L

The EKFZ (ekfz.uni-goettingen.de) at the University Medical Center Göttingen is dedicated to the translation of the four core optogenetic therapeutic 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. Optogenetic therapies typically rely on the combination of a gene therapy to render target cells light-sensitive and a medical device for optical stimulation of the target cells, which involves extensive quality management and innovative regulatory affairs. EKFZ is currently preparing clinical trials for optogenetic restoration of hearing and vision.

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

Your tasks

• Implement and manage a digital quality management system
• Develop a regulatory strategy for optogenetic therapies
• Implement the requirements of the (EU) 2017/745 Medical Device Regulation (MDR) and DIN 13485 including SOPs
• Oversee the structure, maintenance, and continuous improvement of quality management documentation and records
• Prepare technical documentation for active medical devices of risk class III
• Support the regulatory activities related to the gene therapy medicinal product manufacturing
• Collaborate closely with strategic management and development team
• Collaborate closely with regulatory consultants as well as authorities to ensure alignment and compliance
• Coordinate regulatory affairs projects ensuring adherence to deadlines and timelines

Your qualifications

Your qualifications

• Completed scientific degree or technical professional qualification
• Experience in the fields of biotechnology or medical technology, including familiarity with relevant regulatory frameworks (experience in both fields is a plus)
• Proven expertise in regulatory affairs and/or quality management
• Strong team player with flexibility, assertiveness, and the ability to work independently
• Good technical understanding with the ability to analyze complex systems and interdependencies
• Good knowledge of English and German

We offer

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 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.

We look forward to receiving your application!