Chief Executive Officer (CEO) for a Notified Body for Medical Devices

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

karriere.at/jobs/10035962

Chief Executive Officer (CEO) for a Notified Body for Medical Devices

Appreciative environment | independent time management | agile team

About this job

Employment type

Full Time (Permanent employment)

Salary

140,000 EUR to 160,000 EUR yearly

Seniority level

Executive

Work model

Hybrid

Places of work

Wien, Linz

Field of work

Executives, Management

Unfilled vacancies

1 vacancy unfilled for this position

About the company

Employer

Quality Austria Holding GmbH

Number of employees

101 - 500 employees

Locations

Wien, Linz

About US

QMD Services is a Notified Body, specializing in the certification and regulatory compliance of medical devices and in Vitro Diagnostics. QMD Services was designated in 2022 under the IVDR and is well advanced in the designation process under MDR. With a strong commitment to ensuring patient safety and product quality, we provide conformity assessment activities to manufacturers in Europe and also in other regions.

Position Overview

We are looking for an experienced and forward-thinking Chief Executive Officer to take responsibility for the conformity assessment activities within our Notified Body and co-lead QMD through the next steps of growth. The successful candidate combines strong regulatory expertise with practical experience in MDR or IVDR conformity assessment and understands how work within a Notified Body is organised and delivered.

KEY RESPONSIBILITIES

1. Driving growth:

• Drive the sustainable growth of QMD Services by developing services, supporting business opportunities and strengthening the organisation's market position.
• Engage with clients and experts to build trusted, long-term relationships with existing clients, with a strong focus on responsiveness, reliability and service quality.
• Develop and execute a forward-looking strategic plan to achieve QMD's mission, vision, and goals.

2. Responsibility as Head of Notified Body:

• Lead and continuously improve the day-to-day operations of the Notified Body, ensuring efficient, consistent and compliant certification processes.
• develop conformity assessment processes to match clients needs for timely and efficient certification processes.
• Monitor operational metrics and make data-driven decisions to optimize performance and cost.

3. Regulatory Expertise:

• Stay abreast of evolving regulatory requirements and industry standards, ensuring the organization's services remain compliant.
• Collaborate with regulatory agencies and industry associations to stay abreast and shape policy changes.

4. Team Leadership and Development:

• Lead an international team of experts through trust, clarity and professional appreciation.
• Provide mentorship and guidance to staff members to facilitate their growth and development.

QUALIFICATIONS

• Substantial professional experience within a Notified Body for medical devices or in vitro diagnostic medical devices.
• Previous managerial responsibility within a Notified Body or leadership experience in a comparable regulated expert organisation.
• Strong knowledge of the MDR and/or IVDR, relevant guidance and standards, including ISO 13485.
• Practical experience in the 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.
• Proven ability to manage operations, establish priorities and support efficient project delivery.
• Client-oriented mindset and experience in developing and maintaining professional business relationships.
• An approachable, supportive and inclusive leadership style that builds trust, encourages knowledge-sharing and helps people grow.
• Excellent interpersonal and communication skills in an international and intercultural environment.
• German and very good English language skills are mandatory.

Details about this job

Full Time (Permanent employment)

• Monday to Friday
• 40 hours
• Willingness to travel 40%

Places of work

• Wien
• Linz

Must-have skills

• Regulatory Compliance
• Medical Devices Knowledge
• Quality Management Systems
• Strategic Planning
• Risk Management

Details about this job

Full Time (Permanent employment)

• Monday to Friday
• 40 hours
• Willingness to travel 40%

Places of work

• Wien
• Linz

Must-have skills

• Regulatory Compliance
• Medical Devices Knowledge
• Quality Management Systems
• Strategic Planning
• Risk Management

Salary

The actual salary depends on your qualifications and experience and is between 140,000 EUR und 160,000 EUR gross per year (on a 40-hour basis). The salary is paid 14 times per year.

140,000 EUR

160,000 EUR

Overtime

This is an all-in salary, which already includes any accrued overtime.

All infos regarding your application

Required application documents:

• Résumé
• Cover letter

Contact person

Claudia Kerpe
Leitung HR

QMD Services is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.

Please send your application by November 30, 2026.

www.qualityaustria.com/