Risk Manager Medical Devices

D.Med Consulting GmbH; Hamburg; Hybrid; EUR 70.000 - 90.000; Vollzeit

Benefits dieser Stelle

Betriebliche Altersvorsorge

JobRad

Team-Events

Corporate Benefits

Zusammenfassung

D.Med Consulting GmbH mit Sitz in Hamburg bietet eine anspruchsvolle Position im Risikomanagement und Regulatory Affairs für Medizinprodukte. Sie arbeiten an Risikobewertungen, technischen Dokumentationen und internationalen Regularien innerhalb eines interdisziplinären Teams.

Sie verfügen über eine technische Ausbildung oder ein entsprechendes Studium, Erfahrungen in MDR/ISO-Regeln und Methoden wie FMEA/FTA. Ein modernes Arbeitsumfeld in Hamburg sowie flexible Arbeitsmodelle gehören zum Angebot.

Qualifikationen

• Abgeschlossenes technisches Studium oder Ausbildung im relevanten Bereich
• Mehrjährige Berufserfahrung in Produktentwicklung, Risikomanagement, Qualität oder Regulatory Affairs für Medizinprodukte
• Fundierte Kenntnisse MDR, ISO 14971, ISO 13485, IEC 62304, sowie Methoden wie FMEA und FTA

Aufgaben

• Identifikation, Analyse, Bewertung und Dokumentation von Produkt-Risiken gemäß ISO 14971
• Bewertung sicherheitsrelevanter Hazards in Zusammenarbeit mit technischen Experten
• Unterstützung von Cross-Functional-Teams bei Risikokontrollmaßnahmen und deren Wirksamkeit
• Identifikation, Untersuchung und GAP-Analyse regulatorischer Anforderungen für Medizinprodukte
• Erstellung, Prüfung und fortlaufende Pflege technischer Dokumentation gemäß Standards und Regulierung
• Entwicklung von Marktzugangs- und regulatorischen Strategien für aktive/nicht-aktive Medical Devices und SaMD

Kenntnisse

Risikomanagement

Regulatorische Kenntnisse

Teamfähigkeit

Analytische Fähigkeiten

Entscheidungsstärke

Kommunikationsfähigkeit

Ausbildung

Technische Ausbildung in Medizintechnik

Tools

FMEA

FTA

Jobbeschreibung

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 full or part-time for a

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.

We are looking forward to meeting you!