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
Risk Manager Medical Devices (m/f/d)
- 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)
- 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
- 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
Join us in shaping the future of healthcare by ensuring the safety and reliability of life-saving medical devices — your expertise in risk management can make a real difference. Please send your application to [email protected] or click.
We are looking forward to meeting you!
D.Med Consulting GmbH | Bernhard-Nocht-Str. 99 | 20359 Hamburg | +49 211 650 415 14
