<div class="show-more-less-html__markup show-more-less-html__markup--clamp-after-5 relative overflow-hidden"> <p><strong>Join D.Med Consulting GmbH – Pioneering Medical Device Technologies</strong></p><p>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.</p><p><br/></p><p>For our office in Hamburg and at the earliest possible starting date we are looking for a</p><p><br/></p><p>Quality and Regulatory Affairs Manager Medical Devices (m/f/d)</p><p><br/></p><p><strong>Your responsibilities:</strong></p><ul><li><strong>Regulatory Analysis</strong>: Conducting regulatory GAP analyses and overseeing the interpretation and integration of applicable global regulatory requirements for medical devices into internal processes</li><li><strong>Technical Documentation</strong>: Creating, reviewing, and maintaining high-quality technical documentation in compliance with MDR, IVDR, and other relevant standards</li><li><strong>Market Access &amp; Registration:</strong> 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</li><li> <strong>Quality Management Systems (QMS)</strong>: Establishing, maintaining, and continuously improving Quality Management Systems (QMS) according to ISO 13485, including the preparation and maintenance of related documentation</li><li><strong>Regulatory Developments: </strong>Continuously monitoring and evaluating changes in global regulatory landscapes and implementing necessary updates to QMS and technical documentation</li><li><strong>Risk Management</strong>: 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</li><li> <strong>Safety Assessment</strong>: Assessing the safety relevance of hazards in close collaboration with cross-functional teams and ensuring alignment with regulatory and quality requirements</li></ul><p> </p><p><strong>Your profile:</strong></p><ul><li>Degree in medical technology, engineering, natural sciences, or a related technical field</li><li>Several years of hands-on experience in quality management and/or regulatory affairs within the medical device industry</li><li>In-depth understanding of MDR, ISO 13485, ISO 14971, IEC 62304, and risk and safety analysis methodologies (FMEA, FTA)</li><li>Proven knowledge in product development and risk management, especially with systems combining hardware, software, and mechanics</li><li>Strong communication skills and the ability to work effectively in interdisciplinary teams</li><li>Structured, independent, and goal-oriented working style</li><li>Strong analytical thinking and sound decision-making capabilities</li><li>Fluent in English; proficiency in German is a plus</li></ul><p> </p><p><strong>What we offer: </strong></p><ul><li>A diversified and challenging environment combined with a high degree of freedom for the implementation of innovative ideas</li><li>A permanent employment contract with performance-related pay at an international and promising employer</li><li>A modern workplace in spacious and bright offices in the heart of Hamburg with a view of the River Elbe</li><li>A supportive working atmosphere in a dynamic team with short decision paths</li><li>An individually tailored “on the job” training and professional development opportunities</li><li>Personal added values such as a company pension scheme, team events, employee discounts, bike leasing and much more</li></ul><p> </p><p>Do you see this job offer as a personal challenge and do you want to make a difference? Then share your application, including your salary expectations and your earliest possible starting date, with us by clicking on “Apply for job”.</p><p><br/></p><p>We are looking forward to meeting you!</p><p><br/></p><p><strong>D.Med Consulting GmbH</strong> | Bernhard-Nocht-Str. 99 | 20359 Hamburg | +49 211 650 415 14</p> </div>