Risk Management Expert (f/m/x)

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

Risk Management Expert (f/m/x)

Full time (40 hours per week)

Challenges you conquer:

* Contribution to the risk management for the MedAustron medical devices life cycle, according to ISO 14971
* Risk management activities for the medical product development
* System and risk analysis for the intended use of a medical device (top level, system level, component level)
* System and risk analysis for industrial hazards (HAZOP)
* Safety for medical devices and industrial systems (risk-based safety architecture)
* Medical software risk management
* Cybersecurity for medical devices (risk-based security architecture)

A background that impresses:

* Completed technical university studies
* Basic technical knowledge
* Understanding of medical device risk management
* Knowledge and understanding of international safety standards for medical devices (IEC 62304, IEC 81001-5-1)
* Experience in ISO 14971 and with quality standards and regulatory affairs (ISO 13485, Medical Device Regulation) is an advantage
* Good written and verbal communication in English language
* Analytical mindset and problem solving skills
* Proactiveness and ability to work in a team

A unique offer that inspires:

For legal reasons, we must point out that the minimum salary for this position is EUR50,500,-- gross per year (full-time basis). However, our attractive salary packages are based on current market salaries.

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

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