Regulatory Expert (f/m/x)

jobsin; Wiener Neustadt; Vor Ort; EUR 55.000 - 85.000; Vollzeit

Zusammenfassung

MedAustron International GmbH in Austria seeks a Regulatory Expert (f/m/x) to drive regulatory activities for medical device development. You will shape regulatory strategy, ensure compliance with MDR, CE marking, and FDA processes, and support audits to advance patient-focused technologies.

You will collaborate with interdisciplinary teams, define design-control workflows, contribute to risk management per ISO 14971, and maintain technical documentation in line with ISO 13485 and IEC 62304,

Qualifikationen

• Completed technical or scientific degree in Medical Engineering, Mechanical Engineering, Electrical Engineering, Physics, or a related field.
• Strong understanding of product development processes and regulatory requirements in medical device development.
• Experience with ISO 13485 and IEC 62304 is advantageous.
• Excellent organizational and structured, solution-oriented working style.
• Strong communication skills and team-oriented mindset.
• Very good German and English language skills, both written and spoken.

Aufgaben

• Contribute to compliant execution of regulatory activities for medical device development.
• Coordinate and execute usability engineering activities per IEC 62366.
• Contribute to risk management activities per ISO 14971.
• Define workflows and processes, especially design control.
• Prepare technical documentation.
• Implement regulatory strategies to obtain MDR CE marking and FDA 510(k); participate in audits.

Kenntnisse

Regulatory affairs

Usability engineering

Risk management

Design control

Technical documentation

Regulatory strategy

Audits

ISO 14971

IEC 62366

ISO 13485

IEC 62304

German language

English language

Ausbildung

Medical Engineering

Mechanical Engineering

Electrical Engineering

Physics

Jobbeschreibung

Share our spirit and become part of our team as a Regulatory Expert (f/m/x)

Who we are:

MedAustron International GmbHis 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 whereyour expertise will directly contribute to the successful development of innovativemedical 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