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Gehalt (Schätzung)
Grobe Schätzung: 44.000 €–58.000 €/Jahr
Über diese Stelle
*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”.
