Website D.Med Consulting GmbH
D.Med Consulting GmbH is a joint venture between Fresenius Medical Care AG & Co. KGaA (51%) and the D.Med Healthcare Group (49%), one of the world’s leading operators of medical devices and medical products in the field of Nephrology, Cardiology and Internal Medicine. Founded in 2011 and seated in Hamburg, D.Med Consulting GmbH provides first-class consulting services focused on Extracorporeal Therapies.
To keep pace with our growing business we are looking for an ambitious candidate to join our team at our Hamburg office as part of a
Regulatory Affairs Manager (m/f/d)
- Identification and investigation of regulatory requirements
- GAP Analysis of regulatory requirements
- Support in creation and update of technical documentation
- Project management support
- Support in maintenance of QMS acc.to EN ISO 13485
- 2 years of relevant experience in regulatory affairs for medical devices or similar
- Good understanding of design control process
- Good knowledge of EN ISO 13485 and MDR
- Knowledge of registration process for medical devices in the USA is a plus
- Good communication and team player skills
- Fluency in English (written and spoken)
- A varied and challenging job combined with a high degree of freedom to implement innovative ideas
- A modern workplace in spacious and bright offices in the heart of Hamburg with a view of the river Elbe
- A collegial working atmosphere in a dynamic team with short decision-making processes
- An open-ended employment contract with performance-related remuneration with an international and promising employer
- On-the-job training tailored to your individual needs and opportunities for professional development
- Personal added value such as company pension scheme, team events, employee discounts, etc.
Have we aroused your interest in this exciting and varied task with development opportunities? Then please send your complete application documents with details of your earliest possible starting date to Gabriele Zebisch () or per click on „Apply for job“.
D.Med Consulting GmbH | Bernhard-Nocht-Str. 99 | 20359 Hamburg, Deutschland | Tel: +49 211 650 415 13