Hybrid Risk Management Expert

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:

• Promotion of training and further education
• Company cell phone & notebook
• Parking space for two-wheelers, four-wheelers and electric vehicles (incl. free e-car charging
• station)
• Snacks, drinks & meal allowance
• Fitness offers
• Company health promotion & occupational physician
• Wide range of employee discounts
• Discounts on various insurance offers
• Good transport connections
• International working environment
• Discounts with partner companies
• Employee events & afterworks

For the advertised position we offer a gross annual salary from € 50,500,-- (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 .

You are the right person for this job?

Take the next step in your career and send us your application via our online application-tool.

Your contact:

Elisabeth Pfingstl, MA

HR Generalist

T +43 664 80878-161