Quality & Regulatory Affairs Manager Medical devices (m/f/d)

D.Med Consulting GmbH; Hamburg; On-site; EUR 85,000 - 120,000; Full time

Benefits offered by this job

Company pension scheme

Team events

Employee discounts

Bike leasing

On-the-job training

Job summary

D.Med Consulting GmbH in Hamburg seeks an experienced Quality and Regulatory Affairs Manager Medical Devices (m/f/d). You will lead regulatory analyses, create MDR/IVDR-compliant documentation, manage market access, and drive QMS improvements across hardware, software and mechanics.

Fluent English is required; German is a plus. Join a dynamic medical technology consultancy offering a permanent contract, attractive development opportunities, and a collaborative, international team in a modern

Qualifications

• Proven 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).
• Experience with product development and risk management for hardware, software and mechanics.

Responsibilities

• Regulatory analysis: guide regulatory GAP analyses and integrate global requirements into internal processes.
• Technical documentation: create and maintain MDR/IVDR-compliant docs and related records.
• Market access & registration: develop strategies for devices including SaMD.
• QMS: establish and improve ISO 13485-aligned systems and documentation.
• Regulatory developments: monitor changes and update QMS/docs accordingly.
• Risk management: lead product-related risk analyses per ISO 14971.

Skills

Regulatory affairs

Quality management

MDR knowledge

ISO 13485

ISO 14971

IEC 62304

FMEA

FTA

Software as a Medical Device (SaMD)

Cross-functional collaboration

Education

Degree in medical technology/engineering/natural sciences

Job description

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 an experienced Quality and Regulatory Affairs Manager Medical Devices who brings hands-on expertise, a proactive mindset, and the ability to independently drive projects forward. If you enjoy taking responsibility, applying your expertise to challenging projects, and making a real impact as part of a collaborative team, join our team as

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

We are looking forward to meeting you!

About us:

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.