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

QMD Services GmbH; Wien, Linz; Hybrid; EUR 180,000 - 300,000; Full time

Job summary

QMD Services GmbH, an established Notified Body in Austria, seeks an experienced Chief Executive Officer to oversee conformity assessment activities and guide the Notified Body through next growth phases.

The role requires deep MDR/IVDR regulatory expertise, practical conformity assessment experience, and strong leadership in an international, regulated environment. You will drive strategy, client relationships and high-quality certification delivery.

Qualifications

• Substantial Notified Body experience for medical devices or IVDs.
• Prior managerial responsibility within a Notified Body or similar regulator.
• Deep MDR/IVDR knowledge plus ISO 13485 understanding.
• Practical experience assessing conformity documentation for medical devices/IVDs.
• Strong ability to assess complex regulatory/technical issues and decide.
• Track record of managing operations and delivering projects.
• Client-oriented mindset with strong relationship-building.
• Inclusive, trustworthy leadership fostering growth.
• Excellent intercultural communication in international setting.
• German and English language skills mandatory.

Responsibilities

• Drive sustainable growth by developing services, opportunities and market position.
• Engage with clients and experts to build long-term trusted relationships.
• Develop and execute a strategic plan to achieve QMD's mission and goals.
• Lead and improve Notified Body day-to-day operations and certification processes.
• Develop conformity assessment processes to meet client needs.
• Monitor operational metrics and optimize performance and costs.
• Stay abreast of evolving regulatory requirements and collaborate with agencies.
• Lead an international team with trust, clarity and professional development.

Skills

Notified Body experience

MDR/IVDR knowledge

Leadership / people mgmt

Conformity assessment exp

Regulatory policy awareness

Client relationship mgmt

Intercultural communication

German language

English language

Job description

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 in 2024 für the 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. 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.

QUALLIFICATIONS

• 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.