Quality & Regulatory Affairs Manager Medical devices (m/f/d)

vor 2 Wochen

Hamburg, Deutschland D.Med Consulting GmbH Vollzeit

Your responsibilities: Conducting regulatory GAP analyses and overseeing the interpretation and integration of applicable global regulatory requirements for medical devices into internal processes Creating, reviewing, and maintaining high-quality technical documentation in compliance with MDR, IVDR, and other relevant standards 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 Establishing, maintaining, and continuously improving Quality Management Systems (QMS) according to ISO , including the preparation and maintenance of related documentation Continuously monitoring and evaluating changes in global regulatory landscapes and implementing necessary updates to QMS and technical documentation Leading the identification, analysis, evaluation, and documentation of product-related risks for medical devices in accordance with ISO , with a strong focus on quality and compliance Assessing the safety relevance of hazards in close collaboration with cross-functional teams and ensuring alignment with regulatory and quality requirements Supporting and guiding project teams in the technical development and implementation of risk control measures, including effectiveness verification from a quality management perspective 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 , ISO , IEC , 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 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”. We are looking forward to meeting you D.Med Consulting GmbH | Bernhard-Nocht-Str. 99 | Hamburg |

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