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

• *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 |