Risk Management Specialist

vor 4 Wochen

Freiburg, Baden-Württemberg, Deutschland Thermo Fisher Scientific Vollzeit

At Thermo Fisher Scientific, we are seeking a highly skilled Risk Management professional to join our team in Freiburg. As a Risk Manager, you will play a critical role in ensuring the quality and safety of our products, particularly EliA products.

Key Responsibilities:

  • Implement and coordinate Risk Management activities related to EliA products in Freiburg, in collaboration with other Quality Management members and departments.
  • Develop and release Risk Management procedures, instructions, and forms.
  • Provide training on the Risk Management process as needed.
  • Support New Product Development, Product Care, and Compliance projects.
  • Act as Chair of the IDD Risk Management Board, facilitating and supporting Risk Management meetings to evaluate risks and update risk files.
  • Coordinate all Risk Management Process interfaces.
  • Drive the ongoing Risk Management Remediation Project.
  • Ensure Risk Management Reporting.

Requirements:

  • University degree in natural or pharmaceutical science (health science, biology, biochemistry area) with relevant professional experience.
  • Strong theoretical and practical knowledge in 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.
  • People management, communication, and problem-solving skills.
  • Experienced in Project Management.
  • Independent and well-structured approach to tasks.
  • Excellent spoken and written language skills in German and English.
  • Auditor certification is a plus.

What We Offer:

  • Employment with an innovative, future-oriented organization.
  • Outstanding career and development prospects.
  • Company pension scheme and other fringe benefits.
  • Exciting company culture which stands for integrity, intensity, involvement, and innovation.

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