Regulatory Expert (f/m/x)

EBG MedAustron GmbH; Wiener Neustadt; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

EBG MedAustron GmbH is seeking a Regulatory Expert to oversee regulatory activities for medical device development in Wiener Neustadt, Austria. This role requires a strong understanding of product development processes, regulatory requirements, and a technical degree in medical or engineering fields.

The candidate will contribute to innovative projects that aim to enhance patient care through advanced medical technologies. Excellent German and English skills are essential.

Qualifikationen

• Completed technical or scientific degree in a relevant field.
• Strong understanding of regulatory processes in medical device development.
• Experience with ISO 13485 and IEC 62304 is an advantage.

Aufgaben

• Execute regulatory activities for medical device development.
• Coordinate usability engineering activities per IEC 62366.
• Manage risk management activities per ISO 14971.
• Define workflows and processes regarding design control.
• Prepare technical documentation.
• Implement regulatory strategies for medical device approvals.

Kenntnisse

Product development processes

Regulatory requirements

ISO 13485

IEC 62304

Organizational skills

Communication skills

German language skills

English language skills

Ausbildung

Technical or scientific degree (Medical Engineering, Mechanical Engineering, etc.)

Jobbeschreibung

MedAustron International GmbH is a subsidiary of EBG MedAustron GmbH and realizes international technology projects in 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 activities 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.

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

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

For the advertised position we offer a minimum gross annual salary based on the classification in use group IV of the collective agreement for white‑collar workers in the metal industry, with the possibility of a significant overpayment, depending on professional qualifications and experience.

Ready to grow with us as a Regulatory Expert?

Take the next step in your career and send us your application documents using our online application tool.