Working languages: GermanJob sector: Other research and experimental development on natural sciences and engineeringWork schedule: Full-timeContract type: Contract to hireOccupation: Technical sales representativeNumber of posts: 1Job details:MED AUSTRONEBG 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.Become a part of the Medical Device Affairs Team as 1 Risk Management Expert (f/m/x) Full time (40 hours per week). 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.CHALLENGES you conquer:Contribution to the risk management for the MedAustron medical devices life cycle, according to ISO 14971Risk management activities for the medical product developmentSystem 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 managementCybersecurity for medical devices (risk-based security architecture)A BACKGROUND that impresses:Completed technical university studiesBasic technical knowledgeUnderstanding of medical device risk managementKnowledge 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 advantageGood written and verbal communication in English languageAnalytical mindset and problem solving skillsProactiveness and ability to work in a teamA UNIQUE OFFER that inspires:Flexible working hoursEducation & trainingCompany mobile & laptopEasy transport connectionSnacks, drinks, meals allowanceJob location:South Lower Austria - AustriaEmployer:Name: EBG MedAustronSector: Other research and experimental development on natural sciences and engineeringOrganisation size: Large enterpriseRemuneration:Remuneration basis: Fix base paid Salary From 50500 EUR (Initial rate of compensation)How to apply:How to apply Schriftliche Bewerbung, Onlinebewerbung - über Homepage Job vacancy ID ID-16534325
#J-18808-Ljbffr