Global Medical Devices CEO - Regulatory & Growth (Hybrid)

Quality Austria Holding GmbH; Wien; Hybrid; EUR 140,000 - 160,000; Full time

Job summary

Quality Austria Holding GmbH is seeking an experienced Chief Executive Officer to lead the Notified Body services for medical devices and IVDR conformity assessment. You will drive growth, oversee certification processes, and steer strategic planning within a global, regulated environment.

The role requires strong MDR/IVDR knowledge and international leadership. The position is based in Austria with hybrid work arrangements, and travel as needed.

Qualifications

• Substantial professional experience within a Notified Body for medical devices or in vitro diagnostic medical devices.
• Managerial responsibility within a Notified Body or leadership in a comparable regulated expert organisation.
• Strong knowledge of the MDR and/or IVDR, relevant guidance and standards, including ISO 13485.
• Practical experience in conformity assessment of technical documentation for medical devices and/or IVDs.
• Ability to assess complex regulatory and technical matters, exercise sound judgement and make clear decisions.

Responsibilities

• Drive the sustainable growth of QMD Services by developing services and strengthening market position.
• Lead and continuously improve the day-to-day operations of the Notified Body and conformity assessment processes.
• Stay abreast of evolving regulatory requirements and shape policy changes.
• Lead an international team of experts and provide mentorship for staff development.

Skills

Regulatory Compliance

Medical Devices Knowledge

Quality Management Systems

Strategic Planning

Risk Management

Job description

Quality Austria Holding GmbH is seeking an experienced Chief Executive Officer to lead the Notified Body services for medical devices and IVDR conformity assessment. You will drive growth, oversee certification processes, and steer strategic planning within a global, regulated environment.

The role requires strong MDR/IVDR knowledge and international leadership. The position is based in Austria with hybrid work arrangements, and travel as needed.