Head of Quality Management & Regulatory Affairs (m/f/d)

Hamburg · Full-time · Permanent

For my client, a growing company in healthcare technology and point-of-care diagnostics, I am looking for an experienced professional to take ownership of Quality Management, Regulatory Affairs, Purchasing and Supply Chain.

The company commercializes an innovative diagnostic platform for rapid blood testing and is expanding internationally. This is an opportunity to join the leadership team and shape the processes that support its next phase of growth.

Reporting directly to executive management, you will lead a small operational team and ensure that quality, regulatory compliance and product availability keep pace with commercial expansion.

The role combines strategic responsibility with hands-on involvement. It suits someone who enjoys building practical, scalable processes and taking ownership across several operational areas.

Quality Management & Regulatory Affairs

• Own and continuously improve the existing Quality Management System, Quality Manual and related processes.
• Ensure quality standards are consistently applied in daily operations and relevant regulatory requirements are met.
• Maintain regulatory documentation for devices, diagnostic tests and suppliers.
• Oversee quality inspections, product complaints and supplier escalations.
• Coordinate appropriate action on significant quality issues, including potential sales suspensions or product recalls.
• Support product launches in new international markets from a quality and regulatory perspective.

Purchasing & Supply Chain

• Take overall responsibility for procurement, supplier relationships, inventory planning and product availability.
• Manage purchasing in close collaboration with Sales, manufacturing partners and test suppliers.
• Develop forecasts and balance availability, product shelf life, inventory levels and working capital.
• Negotiate with suppliers and monitor and optimize procurement costs.
• Develop the logistics setup as the company grows, including evaluating external warehousing and fulfillment partners.

Operational Development & Leadership

• Improve existing processes and establish scalable structures.
• Support the development of the diagnostic test portfolio and the onboarding of new suppliers.
• Play a key role in the introduction of a modern ERP system.
• Lead and develop a small team covering logistics, order processing and warehouse support.
• Represent your areas of responsibility within the leadership team and towards external stakeholders.
  

• Several years of relevant professional experience, ideally five or more.
• Strong expertise in both Quality Management and Regulatory Affairs within medical devices or a similarly regulated healthcare environment.
• Sound knowledge of relevant regulations, particularly MDR and IVDR.
• Practical experience in procurement and supply chain, including forecasting, supplier management and inventory planning.
• Experience with ERP systems and operational process improvement.
• The ability to work independently, make decisions and take broad ownership.
• A structured, pragmatic and hands-on approach.
• Strong negotiation and communication skills, intercultural competence and confidence working with legal and contractual documents.
• Excellent English skills at C1 level.

Additional experience would be an advantage:

• Diagnostics, IVD, biomarkers or point-of-care products.
• Building or professionalizing processes in a start-up, scale-up or SME.
• ERP implementation or migration.
• Scaling logistics or working with external fulfillment providers.
• Initial team leadership experience.
• A degree in business, economics or a related field.
• German language skills; Russian is a particular plus.

A diagnostics background is welcome but not essential. The key requirement is the combination of strong Quality and Regulatory expertise with hands-on procurement and supply chain experience.

• A leadership role with a direct reporting line to executive management.
• Significant scope to shape processes and contribute to international growth.
• A varied remit across quality, regulation, procurement and operations.
• An entrepreneurial culture with short decision-making paths.
• An office in Hamburg’s HafenCity and a hybrid working model, currently typically including one home-office day per week.
• A permanent, full-time position with a start date as soon as possible.