Risk Management Expert

FRESENIUS MEDICAL CARE

Apply risk management process throughout product lifecycle
Develop and maintain risk analyses and risk management file
Knowledge of iso 14971 and mdr regulations
The role focuses on ensuring the safety of medical devices by applying the risk management process throughout the entire product lifecycle

Job Summary

  • The role focuses on ensuring the safety of medical devices by applying the risk management process throughout the entire product lifecycle.
  • Candidates will lead planning and execution of risk management activities in compliance with applicable standards and regulations.
  • The position offers individual opportunities for self-determined career planning within a culture that encourages innovative thinking.

Matching Summary

The role focuses on ensuring the safety of medical devices by applying the risk management process throughout the entire product lifecycle.

Skills & Requirements

Must-have

  • Apply risk management process throughout product lifecycle
  • Develop and maintain risk analyses and Risk Management File
  • Knowledge of ISO 14971 and MDR regulations

Nice-to-have

  • Experience with TrackWise or QTRAK tools
  • Familiarity with Windchill PDM tools
  • Proactive problem-solving attitude

Key Requirements

  • Scientific degree required
  • Minimum 2 years experience in Regulatory Affairs or Quality
  • Fluent English proficiency required

Work Rights

Not specified

Tailored Resume

Cover Letter