Group Lead Medical Device Affairs

Vor 4 Tagen

Wiener Neustadt, Österreich MedAustron EBG Vollzeit

**EBG 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.

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 Directive as well as for the system architecture of our therapy accelerator.

**Become part of the Medical Device Affairs team as**

**Group Lead Medical Device Affairs (f/m/x)**:
**full-time (40 hours weekly)**:
**Challenges** you conquer:

- Leading a team of highly trained international experts
- Representation of the team towards stakeholders and external partners
- Continuous improvement of existing manufacturer processes (according to ISO 13485)
- Support the implementation of development projects to drive our technical innovations
- Support of international projects directly and via the coordination of team members
- Support of other organizational units regarding team expertise
- Management of the group’s resources (personnel and budget)

**A background** that impresses:

- Technical university degree (Master, PhD)
- Minimum of 5 years of occupational experience in regulatory affairs preferably in the development and/or maintenance of medical devices
- Experience in working with medical products and certification (MDR) and ideally with internal and external audits
- Knowledge of quality standards and regulatory affairs as ISO 13485, and as an advantage EN ISO 14971, IEC 60601-1
- Relevant experience in successfully leading an international team and in operating at a strategic level
- Fluent in verbal and written communication in English and German
- Hands-on mentality and achieving defined targets
- Proactive and strong in communication

**A unique offer** that inspires:
For the advertised position we offer a gross annual salary from € 65.000;
- (All-In contract, 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 here.

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