Chief Executive Officer (CEO) to co-lead our Notified Body for Medical Devices

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 seeking a visionary and dynamic Chief Executive Officer (CEO) to co-lead our Notified Body for Medical Devices and IVDs. The CEO will play a pivotal role in shaping the organization’s strategy, ensuring growth, and building the future structures fit for long term sustainable activity in the highly regulated medical device industry. The successful candidate will possess a deep understanding of regulatory compliance, medical device certification, and industry trends. The position of CEO is shared. The definition of responsibilities within the Executive Board will be defined depending on competences of the candidate.

KEY RESPONSIBILITIES

1. Strategic Leadership:
   • Develop and execute a forward-looking strategic plan to achieve the company’s mission, vision, and goals.
   • Lead organizational growth initiatives, including expanding service offerings, entering new markets, and exploring strategic partnerships.
2. Financial Management:
   • Develop and manage the company’s budget, ensuring fiscal responsibility and sustainable growth.
   • Monitor key financial metrics and make data-driven decisions to optimize financial performance.
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 influence and shape policy changes.
4. Operational Excellence:
   • Oversee the daily operations of the Notified Body, ensuring efficiency, quality, adherence to regulatory standards and patient safety.
   • Implement robust processes and supporting IT systems to maintain the highest levels of integrity and accuracy in our certification processes.
5. Team Leadership and Development:
   • Build and lead a high-performing international team of professionals, fostering a culture of innovation, collaboration, and continuous improvement.
   • Provide mentorship and guidance to staff members to facilitate their growth and development.
6. Client Relations:
   • Cultivate and maintain strong collaboration with medical device manufacturers, ensuring exceptional client satisfaction and retention.
   • Foster a culture of customer-orientation to address customer certification needs and challenges.
7. Industry Thought Leadership:
   • Represent QMD Services as a sector leader, speaking at conferences, trade fairs, publishing articles, and participating in relevant forums.
   • Drive innovation within the organization and contribute to the advancement of medical device certification practices in relevant European Bodies.

QUALIFICATIONS

• German language on native level and very good English language skills are basic requirements.
• Master’s/- or PhD degree (preferred in a medical device related field).
• Financial acumen and budget management skills.
• Proven executive leadership experience, preferably in certification, medical device industry or a closely related field.
• Proven expertise and outstanding talent in the leadership of expert organizations, preferably on an international basis.
• Demonstrated success in strategic planning and execution.
• Exceptional interpersonal and communication skills.
• A track record of building and leading high-performing teams.
• Basic knowledge of medical device and IVD regulations, including ISO 13485, and other international standards desirable.
• Regulatory affairs and compliance expertise desirable.
• Experience in human resources management within an intercultural team is an advantage.