Sr./ Regulatory Expert (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

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.

Your responsibilities

• 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

Your profile

• 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

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