Quality and Regulatory Affairs Manager Medical Devices (m/f/d)

For our office in Hamburg and at the earliest possible starting date we are looking for a **Quality and Regulatory Affairs Manager Medical Devices (m/f/d)** ### **Your responsibilities** * **Regulatory Analysis**: Conducting regulatory GAP analyses and overseeing the interpretation and integration of applicable global regulatory requirements for medical devices into internal processes * **Technical Documentation**: Creating, reviewing, and maintaining high-quality technical documentation in compliance with MDR, IVDR, and other relevant standards * **Market Access & Registration:** Developing and managing market access and registration strategies for active and non-active medical devices, including Software as a Medical Device (SaMD), with focus on regulatory compliance * **Quality Management Systems (QMS)**: Establishing, maintaining, and continuously improving Quality Management Systems (QMS) according to ISO 13485, including the preparation and maintenance of related documentation * **Regulatory Developments:** Continuously monitoring and evaluating changes in global regulatory landscapes and implementing necessary updates to QMS and technical documentation * **Risk Management**: Leading the identification, analysis, evaluation, and documentation of product-related risks for medical devices in accordance with ISO 14971, with a strong focus on quality and compliance * **Safety Assessment**: Assessing the safety relevance of hazards in close collaboration with cross-functional teams and ensuring alignment with regulatory and quality requirements ### **Your profile** * Degree in medical technology, engineering, natural sciences, or a related technical field * Several years of hands-on experience in quality management and/or regulatory affairs within the medical device industry * In-depth understanding of MDR, ISO 13485, ISO 14971, IEC 62304, and risk and safety analysis methodologies (FMEA, FTA) * Proven knowledge in product development and risk management, especially with systems combining hardware, software, and mechanics * Strong communication skills and the ability to work effectively in interdisciplinary teams * Structured, independent, and goal-oriented working style * Strong analytical thinking and sound decision-making capabilities * Fluent in English; proficiency in 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