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

For our office in Hamburg and at the earliest possible starting date we are looking in part or full-time for a **Risk Manager (Medical Devices) (m/f/d)** We are a dynamic consulting firm in the medical technology sector, driven by a clear ambition: to support companies in developing sustainable and forward-looking solutions. At the heart of our work is a dedicated team that takes ownership, thinks ahead, and brings fresh ideas to life. To strengthen our team, we are looking for an experienced Risk Manager Medical Devices who is passionate about safety, regulatory compliance, and innovative medical technologies. In this role, you will support our clients throughout the entire product lifecycle by identifying and evaluating risks, developing effective mitigation strategies, and ensuring compliance with international regulatory requirements. If you enjoy working at the intersection of technology, regulation, and innovation, while valuing both independent responsibility and close teamwork, you’ll fit perfectly into our team. ### **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