Risk Manager Medical devices

Life Science Nord Management GmbH Hamburg

Stellenbeschreibung:

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 Risk Manager Medical Devices (m/f/d)

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

Role & responsibilities: A varied and challenging role with a high degree of freedom to implement innovative ideas
Work Environment: A modern workplace in spacious and bright offices in the heart of Hamburg, with a view of the Elbe and a collegial working atmosphere in a dynamic team with short decision-making processes
Work flexibility: opportunity to work up to 60% remotely (mobile work)
Employment terms: A permanent employment contract with performance-based compensation at an international and future-oriented company
Onboarding & Development: A personalized "on-the-job" onboarding process and opportunities for professional and personal development
Employee Benefits: Company pension scheme, JobRad (bike leasing), Team events, access to the Corporate Benefits platform…and many more perks

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. Please send your application to - or click "Apply for job. We are looking forward to meeting you

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