EBG MedAustron GmbH in Wiener Neustadt operates one of the most modern centers for particle therapy and research in Europe. Cancer patients are treated with an innovative form of radiation therapy with protons and carbon ions. In addition to cancer treatment the facility is also used for translational research.

Our Medical Device Affairs team is responsible for the implementation of the quality management system according to EN ISO 13485, for the compliance with the Medical Device Regulation, as well as for the system architecture of our therapy accelerator.

Become a part of the Medical Device Affairs Team as 

Change Manager (f/m/x)

Full-time (40 hours weekly) / Start date: as soon as possible

Challenges you conquer:

• Responsible for the design change management process in accordance with ISO 13485 and the Medical Device Regulation 2017/745 requirements
• Improving and evaluating the change management process and the supporting tools
• Ensuring compliance with the established design change standard procedures, instructions, templates  (ensure that colleagues do not override them)
• Ensuring completeness, correctness of change requests, from preparation to approval and implementation, and alignment with the timeline
• Participation in the Change Advisory Board
• Classification of changes and facilitating the change impact assessments
• Performing Post-implementation review of the changes
• Measuring and reporting on the performance & maturity of the change management process (Key Performance Indicators), deriving and managing actions for continuous improvement
• The role may evolve over the course of the contract as required

A background that impresses:

• Academic studies (preferable: Bachelor or Master degree) in a technical field
• Experience in the medical device/pharma/automotive industry preferred
• Experience in engineering change management
• High motivation to work in a medical device development environment
• Proactive and engaging personality
• Open-minded, motivated and eager to learn and to share knowledge
• Effective communication skills for collaboration with different stakeholders and working in an international environment
• Fluency in English, knowledge of German is an advantage
• MS Office skills are desirable

A unique offer that inspires:

For the advertised position we offer a gross annual salary from € 49,000,-- (on a full-time basis) with the possibility of overpayment, depending on professional qualifications and experience.

Further information on EBG MedAustron GmbH, our benefits and what matters to us can be found here.

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