Risk Manager Medical Devices

Join D.Med Consulting GmbH – Pioneering Medical Device Technologies

D.Med Consulting GmbH, headquartered in Hamburg, Germany, is a joint venture between Fresenius Medical Care AG (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. The 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. Join our team of dedicated professionals and contribute to groundbreaking advancements in medical device technology. Join us and experience a true partnership in innovation – working hand-in-hand to achieve our customer goals.

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

Your responsibilities:

• Risk Management : Identification, analysis, evaluation, and documentation of product‑related risks for medical devices in accordance with ISO 14971
• Hazard Assessment : Evaluation of safety‑relevant hazards in close collaboration with technical experts
• Risk Control Support : Supporting cross‑functional project teams in the technical development and implementation of risk control measures, including the analysis of their effectiveness
• Regulatory Compliance : Identification, investigation, and GAP analysis of international regulatory requirements for medical devices
• Technical Documentation : Creation, review, and continuous maintenance of technical documentation in line with applicable standards and regulatory frameworks
• Market Access Strategy : Development of tailored market access and regulatory strategies for active, non‑active medical devices, and Software as a Medical Device (SaMD)

Your profile:

• Educational background: Completed technical degree in a relevant field such as medical technology, engineering, computer science, or physics
• Professional experience: Several years of experience in product development, risk management, quality management, or regulatory affairs for medical devices
• Technical expertise: Strong understanding of complex systems involving mechanics, software, and hardware
• Regulatory & standards knowledge : Solid knowledge of key regulations and standards, including MDR, ISO 14971, ISO 13485, IEC 62304, as well as safety analysis methods like FMEA and FTA
• Soft skills: Excellent communication skills and a strong team player mindset
• Working style: Self‑driven, structured, and results‑oriented approach to work
• Analytical abilities: Strong analytical thinking and confident decision‑making capabilities
• Language skills: Fluency in English (spoken and written); German skills are a plus

What we offer:

• Role & responsibilities: A varied and challenging role with a high degree of freedom to implement innovative ideas
• Work Environment: A modern workplace in spacious and bright offices in the heart of Hamburg, with a view of the Elbe and a collegial working atmosphere in a dynamic team with short decision‑making processes
• Work flexibility: Opportunity to work up to 60% remotely (mobile work)
• Employment terms: A permanent employment contract with performance‑based compensation at an international and future‑oriented company
• Onboarding & Development: A personalized “on‑the‑job” onboarding process and opportunities for professional and personal development
• Employee Benefits: Company pension scheme, JobRad (bike leasing), Team events, access to the Corporate Benefits platform…and many more perks