Risk Management Specialist
vor 3 Wochen
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, and providing training as needed.
Key Responsibilities:- Implement ISO 14971 and ensure compliance with regulatory requirements
- Release risk management procedures, instructions, and forms
- Provide training on risk management processes as needed
- Support New Product Development, Product Care, and Compliance projects
- Coordinate risk management activities, including CAPA, NCs, validation, and QMS
- Act as Chair of the IDD Risk Management Board, facilitating risk management meetings and updating risk files
- Drive the ongoing Risk Management Remediation Project
- Prepare risk management reports
- 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
- Employment with an innovative, 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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