Risk Management Specialist

vor 2 Wochen


Freiburg, Baden-Württemberg, Deutschland Thermo Fisher Scientific Vollzeit
Job Title: Risk Manager

Thermo Fisher Scientific Inc. is a global leader in serving science, with a mission to enable our customers to make the world healthier, cleaner, and safer. We are seeking a highly skilled Risk Manager to join our team in Freiburg, Germany.

Job Summary:

The successful candidate will be responsible for initiating, coordinating, and monitoring all Risk Management activities related to EliA products in Freiburg, in collaboration with other Quality Management members and departments. This includes implementing ISO 14971, releasing risk management procedures, instructions, and forms, and providing training as needed.

Key Responsibilities:
  • Implement ISO 14971 and ensure compliance with regulatory requirements
  • Develop and maintain risk management procedures, instructions, and forms
  • Provide training and support to colleagues on risk management processes
  • Support New Product Development, Product Care, and Compliance projects
  • Coordinate risk management activities with other departments and sites
  • Act as Chair of the IDD Risk Management Board and facilitate risk management meetings
Requirements:
  • University degree in natural or pharmaceutical science (health science, biology, biochemistry area) with relevant professional experience
  • Strong theoretical and practical knowledge of Risk Management (ISO 14971)
  • Good Quality Management background (ISO 13485, QSR, MDR, IVDR)
  • Many years of experience in production within Medical Devices, IVD, or Pharma environment
  • Excellent communication and problem-solving skills
  • Experience in Project Management and Auditor certification is a plus
What We Offer:
  • Employment with a future-oriented organization
  • Outstanding career and development prospects
  • Company pension scheme and other fringe benefits
  • Exciting company culture that stands for integrity, intensity, involvement, and innovation


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