Risk and Compliance Manager Medical Devices

Vor 2 Tagen

Hamburg, Hamburg, Deutschland D Consulting GmbH Vollzeit
Job Summary

We are seeking a highly skilled Risk and Regulatory Affairs Manager to join our team at D.Med Consulting GmbH. As a key member of our team, you will be responsible for identifying, analyzing, and mitigating risks associated with medical devices, ensuring compliance with regulatory requirements.

Key Responsibilities
  • Conduct risk assessments and develop mitigation strategies for medical devices
  • Evaluate the safety relevance of hazards and collaborate with technical experts to develop effective risk control measures
  • Support project teams in the development and implementation of risk control measures and analyze their effectiveness
  • Identify, investigate, and analyze regulatory requirements for medical devices
  • Develop and maintain technical documentation and market access strategies for medical devices
Requirements
  • Completed technical studies in a relevant field, such as medical technology, engineering, or computer science
  • Several years of experience in product development, risk management, quality management, or regulatory affairs of medical devices
  • Good technical understanding of systems with mechanics, software, and hardware
  • Knowledge of MDR, ISO, ISO, IEC, and safety analysis (FMEA, FTA)
  • Excellent communication and team player skills
  • Independent and results-oriented work style
  • Good analytical and decision-making skills
  • Fluency in English (written and spoken) - German is a plus
What We Offer
  • A challenging and dynamic work environment with a high degree of freedom for 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
  • A supportive working atmosphere in a dynamic team with short decision paths
  • 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 more

If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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