Quality & Regulatory Affairs Manager Medical devices (m/f/d) D.Med Consulting GmbH

Join D.Med Consulting GmbH – Pioneering Medical Device Technologies 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.

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 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 | 20359
• Hamburg | #J-18808-Ljbffr