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
Sr./ Regulatory Expert (Medical Devices) (m/f/d)
We are a dynamic consulting firm in the medical technology sector, driven by a clear ambition: to support companies in developing sustainable and forward-looking solutions. At the heart of our work is a dedicated team that takes ownership, thinks ahead, and brings fresh ideas to life.
To strengthen our team, we are looking for a flexible all-rounder who enjoys working across a variety of topics and actively contributing to the success of our projects. If you like taking responsibility, working independently, and at the same time value close collaboration within a supportive team, you’ll feel right at home with us.
- Regulatory & Quality Consulting: Advise clients on regulatory and quality strategies across the entire medical device lifecycle, from development to market access and post-market activities
- Regulatory Analysis & Strategy: Conduct GAP analyses and interpret MDR, IVDR, and international regulatory requirements (FDA), translating them into pragmatic implementation plans
- Market Access & Registration: Develop and execute regulatory strategies for global market access, including submissions for medical devices and Software as a Medical Device (SaMD)
- Technical Documentation: Create, review, and maintain technical documentation (e.g., Technical File, CER, RMF) in line with MDR/IVDR requirements
- Quality Management Systems (QMS): Establish, maintain, and improve QMS according to ISO 13485, including process development, documentation, and integration of regulatory requirements
- Design Quality Assurance: Support and ensure compliance of product development processes, including design control activities, design reviews, and Design History File (DHF) documentation in accordance with applicable standards and regulations
- Risk Management & Safety: Lead and support risk management activities according to ISO 14971, ensuring alignment with design, development, and regulatory expectations
- Audits & Compliance: Prepare and support internal and external audits (e.g., notified bodies), including remediation and continuous improvement activities
- Regulatory Intelligence: Monitor global regulatory developments and proactively assess their impact on client projects
- Training & Collaboration & Workshops: Train clients and collaborate with cross-functional teams to ensure effective implementation of regulatory and quality requirements
- Education: Degree in medical technology, engineering, natural sciences, or a related technical field, or 5+ years of experience in QM or RA in the field of medical devices
- Experience: Several years of professional experience in Regulatory Affairs and/or Quality Management within the medical device industry or consulting
- Expertise: Strong knowledge of MDR/IVDR, FDA, ISO 13485, ISO 14971, and ideally IEC 62304 and design control requirements
- Design Assurance: Hands-on experience with design control processes and integration of quality and regulatory requirements into product development
- Technical Scope: Experience with complex medical devices, especially with systems combining hardware, software, and mechanics
- Consulting Mindset: Comfortable working across multiple clients and projects with a flexible, solution-oriented, and hands-on approach. Seeking ownership of projects and tasks
- Analytical Skills: Strong ability to structure complex topics and translate regulatory requirements into practical solutions
- Communication: Confident in client-facing situations with strong interpersonal and presentation skills
- Working Style: Independent, structured, and proactive
- Languages: Fluent in English; German is a strong plus (ambition to improve German skills), any other language is a plus
- 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 | +49 211 650 415 14
