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%), a globally operating provider of medical services and medical products in the fields of nephrology, cardiology and internal medicine. Founded in 2011 and headquartered in Hamburg, D.Med Consulting GmbH stands for first-class research and development as well as consulting services with a focus on extracorporeal therapies.

For our office in Hamburg and at the earliest possible starting date we are looking for a

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

Your responsibilities:

  • 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 SaMD

Your profile:

  • 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

What we offer: 

  • 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

Do you see this job offer as a personal challenge and do you want to make a difference? Then share your application, including your salary expectations and your earliest possible starting date, with us by clicking on “Apply for job”.

We are looking forward to meeting you!

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