Risk & Regulatory Affairs Manager (m/w/d) Medical Devices

Join D.Med Consulting Gmb H – Pioneering Medical Device Technologies

D.Med Consulting Gmb H, headquartered in Hamburg, Germany, is a joint venture between Fresenius Medical Care AG & Co. KGa A (51%) and the D.Med Healthcare Group (49%). Founded in 2011, we are a leading provider of research, development and consulting services specializing in extracorporeal therapies.

Our collaboration with Fresenius Medical Care, the world leader in renal care, and the D.Med Healthcare Group, a renowned provider in nephrology, cardiology, and internal medicine, allows us to offer a comprehensive range of services from concept to implementation.

Risk & Regulatory Affairs Manager (m/w/d) Medical Devices

• Identification, analysis, evaluation, and documentation of product-relevant risks for medical devices acc. to ISO 14971
• Evaluating the safety relevance of hazards in collaboration with technical experts
• Supporting the project teams in the technical development and implementation of risk control measures and analyzing their effectiveness
• Identification, investigation, and GAP Analysis of regulatory requirements for medical devices
• Creation, review, and update of technical documentation
• Creation of market access strategies for active and non-active medical devices as well as Sa MD

• Completed technical studies, e.g. in the field of medical technology, engineering, computer science or physics
• Ideally several years of professional experience in the product development, risk management, quality management or regulatory affairs of medical devices
• Good technical understanding of systems with mechanics, software, and hardware.
• Good Knowledge of MDR, ISO 14971, ISO 13485, IEC 62304 and safety analysis (FMEA, FTA)
• Excellent communication and team player skills
• Independent and results-oriented way of working
• Good analytical and decision-making skills
• Fluency in English (written and spoken) – German is a plus

• A diversified and challenging environment combined with a high degree of freedom for the implementation of innovative ideas
• A permanent employment contract with performance-related pay at an international and promising employer
• A modern workplace in spacious and bright offices in the heart of Hamburg with a view of the River Elbe
• A supportive working atmosphere in a dynamic team with short decision paths
• An individually tailored “on the job” training and professional development opportunities
• Personal added values such as a company pension scheme, team events, employee discounts, bike leasing and much more

D.Med Consulting Gmb H | Bernhard-Nocht-Str. 99 | 20359 Hamburg | +49 211 650 415 14

Daten

1. 01.2025

Wochenstunden: Vollzeit

Kontakt

E-Mail: anne-kathrin.deters@dmed-healthcare.com