Risk Manager (Medical Devices) (m/f/d)

• *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:**
• 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 or click “Apply for job.

We are looking forward to meeting you!

• *D.Med Consulting GmbH** | Bernhard-Nocht-Str. 99 | 20359 Hamburg |

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Source: Statistisches Bundesamt (Destatis), table; dl-de/by-2-0; StarIn's calculation