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

About the Position

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

QMD Services GmbH

Wien, Linz (Österreich)

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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.

Responsibilities

• Driving Growth:

  • Drive the sustainable growth of QMD Services by developing services, supporting business opportunities, and strengthening the organization'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.

• 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.

• 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.

• 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.

Requirements

• 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 organization.
• 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 judgment, 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.

We Offer

• Appreciative environment
• Independent time management
• Agile team

About the Company

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.

How to Apply

Interested candidates are invited to submit their CV, along with a cover letter detailing their qualifications and vision for QMD Services, to [email protected]. QMD Services is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.