Share our spirit and become part of our team as a
Regulatory Expert (f/m/x)
Who we are: MedAustron International GmbH is a subsidiary of EBG MedAustron GmbH and realizes international technology projects in the course of the construction of a new particle accelerator in the rapidly growing medical technology sector. The parent company EBG MedAustron operates one of the most modern centers for ion therapy and research in Europe.
As a
Regulatory Expert , you
will be responsible for regulatory activites for medical device development.
You will work in a meaningful environment where your expertise will directly contribute to the successful development of innovative
medical device projects and help advance technologies that ultimately benefit patients.
A job where you can make a difference:
Contribution to the compliant execution of regulatory activities for medical device development
Coordination and execution of usability engineering activities according to IEC 62366
Contribution to risk management activities according to ISO 14971
Definition of workflows and processes, especially regarding design control
Preparation of technical documentation
Implementation of regulatory strategies to obtain medical device approvals (MDR CE marking, FDA 510(k)), as well as participation in internal and external audits
Skills that make you our strength:
Completed technical or scientific degree, e.g., in Medical Engineering, Mechanical Engineering, Electrical Engineering, Physics, or a comparable field
Strong understanding of product development processes and regulatory requirements in medical device development
Experience with medical device development according to ISO 13485 and with the medical software life cycle according to IEC 62304 is an advantage
Excellent organizational skills and a structured, solution-oriented working style
Strong communication skills and team-oriented mindset
Very good German and English language skills, both written and spoken
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Regulatory Expert (f/m/x) in Wiener Neustadt Arbeitgeber: jobsin
Unser Kunde ist ein hervorragender Arbeitgeber, der ein positives Betriebsklima in einem motivierten Team fördert. Mit abwechslungsreichen Aufgaben und einer intensiven Einarbeitung bietet er nicht nur eine faire Vergütung, sondern auch zahlreiche Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung. Die Lage in der Region ermöglicht es den Mitarbeitenden, in einem dynamischen Umfeld zu arbeiten, das Innovation und Teamarbeit schätzt.
