Risk Manager (Medical Devices) (m/f/d)

D.MED Consulting GmbH; Hamburg; On-site; EUR 80,000 - 110,000; Full time

Benefits offered by this job

Permanent contract with performancepay

Hamburg office

Training and development

Pension scheme

Team events

Bike leasing

Job summary

D.Med Consulting GmbH in Hamburg, Germany, invites an experienced Risk Manager (Medical Devices) to join our dynamic team. You will identify and mitigate risks across the product lifecycle, ensuring compliance with MDR, ISO 14971, ISO 13485, and IEC 62304.

You will collaborate with engineers and regulatory specialists to develop risk controls, prepare technical documentation, and support market access strategies for active devices and SaMD. Fluency in English is required; German is a plus.

Qualifications

• Technical degree in medical technology, engineering, computer science, or physics.
• Several years of experience in risk management, quality management, or regulatory affairs for medical devices.
• Strong knowledge of MDR, ISO 14971, ISO 13485, IEC 62304; risk assessment methods like FMEA/FTA.

Responsibilities

• Identify, analyze, evaluate and document product risks per ISO 14971.
• Hazard assessment in collaboration with technical experts.
• Support cross-functional teams in risk control development and verification.
• Regulatory requirements identification and GAP analysis for medical devices.
• Create, review and maintain technical documentation in line with standards.

Skills

Regulatory knowledge

Analytical thinking

Risk management

Strong communication

Team player

Education

Biomedical Engineering degree

Tools

FMEA

FTA

ISO 14971

ISO 13485

IEC 62304

Job description

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 in part or full-time for a

Risk Manager (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 an experienced Risk Manager Medical Devices who is passionate about safety, regulatory compliance, and innovative medical technologies. In this role, you will support our clients throughout the entire product lifecycle by identifying and evaluating risks, developing effective mitigation strategies, and ensuring compliance with international regulatory requirements. If you enjoy working at the intersection of technology, regulation, and innovation, while valuing both independent responsibility and close teamwork, you'll fit perfectly into our team.

Your responsibilities:

• Risk Management: Identification, analysis, evaluation, and documentation of product-related risks for medical devices in accordance with ISO 14971
• Hazard Assessment: Evaluation of safety-relevant hazards in close collaboration with technical experts
• Risk Control Support: Supporting cross-functional project teams in the technical development and implementation of risk control measures, including the analysis of their effectiveness
• Regulatory Compliance: Identification, investigation, and GAP analysis of international regulatory requirements for medical devices
• Technical Documentation: Creation, review, and continuous maintenance of technical documentation in line with applicable standards and regulatory frameworks
• Market Access Strategy: Development of tailored market access and regulatory strategies for active, non-active medical devices, and Software as a Medical Device (SaMD)

Your profile:

• Educational background: Completed technical degree in a relevant field such as medical technology, engineering, computer science, or physics
• Professional experience: Several years of experience in product development, risk management, quality management, or regulatory affairs for medical devices
• Technical expertise: Strong understanding of complex systems involving mechanics, software, and hardware
• Regulatory & standards knowledge: Solid knowledge of key regulations and standards, including MDR, ISO 14971, ISO 13485, IEC 62304, as well as safety analysis methods like FMEA and FTA
• Soft skills: Excellent communication skills and a strong team player mindset
• Working style: Self-driven, structured, and results-oriented approach to work
• Analytical abilities: Strong analytical thinking and confident decision-making capabilities
• Language skills: Fluency in English (spoken and written); German skills are 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

Join us in shaping the future of healthcare by ensuring the safety and reliability of life-saving medical devices - your expertise in risk management can make a real difference.

We are looking forward to meeting you!

D.Med Consulting GmbH | Bernhard-Nocht-Str. 99 | 20359 Hamburg | [phone]