Associate for Medical Device Regulatory Affairs

vor 1 Monat

Dresden, Deutschland Universitätsklinikum Carl Gustav Carus Vollzeit

The Else Kröner Fresenius Center for Digital Health (EKFZ), a joint center of the Faculty of Medicine Carl Gustav Carus of the Dresden University of Technology and the University Hospital Dresden, promotes translational and interdisciplinary research in the field of digital medicine and health. The center, which is funded by the Else Kröner Fresenius Foundation, cooperates closely with many high-tech specialists in the Dresden research environment and aims to strengthen and promote cooperation with university medicine. Technical innovations should thus benefit patients even more quickly.

Starting at the next possible point, we are looking for a

**Associate for Medical Device Regulatory Affairs (f/m/x)**:
This full-time or part-time position is initially limited to 24 months. A longer-term cooperation is being sought. Remuneration is in accordance with the collective agreement of the Länder (TV-L).

You will work in a multidisciplinary, international environment of researchers, engineers and physicians in support of our common goal to make high-tech innovation quickly accessible to patients. In current projects you will focus on educating and guiding project teams through the technical documentation required for Clinical Trials.

**Your primary responsibilities will include**:

- Regulatory support of academic research teams from the EKFZ working on developing innovative medical devices
- Development of regulatory strategies in compliance with relevant legal regulations (MDR/ IVDR)
- Support in the creation of technical documentations in preparation of clinical trials
- Project management of publicly funded research projects
- Support in the implementation and maintenance of a Quality Management System that conforms to ISO 13485

**Your Profile**:

- Relevant university degree in the field of Clinical Sciences, Natural Sciences, Health Management, Engineering, Computer Sciences or similar
- Knowledge in the areas of MDR, IVDR, ISO 13485 and corresponding standards
- Practical experience in the field of medical engineering and/or in-vitro diagnostics
- Knowledge in the areas of Artificial Intelligence and Software Development (IEC 62304) is a plus
- Desire to work in digital medicine and health topics at their intersection with regulatory affairs
- Willingness to work in an interprofessional and solution-oriented academic environment
- Experience with publicly funded research projects is a plus
- Knowledge in project management
- Written and spoken English and German skills

**We offer**:

- Meaningful work at a prominent medical research, teaching and patient care facility
- Exciting research projects that take medical technology to the next level
- Conditions for an excellent work-life-balance and a team that truly supports it
- Flexible working hours
- Flat hierarchies with the chance to take on responsibility right from the start
- Engaging and supporting ecosystem, also for people new to the field of Regulatory Affairs or who are looking for a new career pathway
- Individual further education and training is encouraged
- Possibility to learn something new every day
- Modern, flexible workstations including laptop computer, docking station and an ergonomic sitting/standing desk
- JobTicket for public transport
- Use of the on-campus fitness studio
- Childcare through partnerships with children's facilities in the vicinity of the university hospital

Disabled persons with equal qualification will be preferred.

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