Head of Quality Management & Regulatory Affairs

Head of Quality Management & Regulatory Affairs Full-Time · Hybrid · Hamburg, Germany Annual Compensation: €70,000–€80,000 About the Role A growing healthcare and diagnostics organization is seeking a senior professional to lead Quality Management, Regulatory Affairs, Procurement, and Supply Chain operations. This is a broad leadership role combining technical responsibility for the Quality Management System (QMS) and regulatory compliance with oversight of purchasing, supplier relationships, inventory management, and supply chain processes. You will work closely with senior management, international suppliers, customers, and internal teams to maintain regulatory compliance, improve operational efficiency, manage quality standards, and build scalable processes in a dynamic healthcare environment. What You’ll Do • Take overall technical responsibility for compliance with and further development of the Quality Management System (QMS). • Ensure compliance with applicable regulatory requirements, including MDR and IVDR. • Lead purchasing and supply chain activities with a focus on product availability and appropriate working capital. • Manage and develop a growing team. • Monitor and optimize product, material, and procurement costs to support profitability targets. • Develop and optimize procurement, supply chain, inventory, quality, and regulatory processes. • Lead communication of quality standards internally and externally. • Represent the organization professionally with suppliers, customers, and other stakeholders. • Manage day-to-day purchasing in close coordination with sales and manufacturing partners. • Conduct ongoing quality inspections against defined product specifications. • Investigate, process, and resolve product complaints. • Further develop, implement, maintain, monitor, and optimize the QMS. • Report directly to senior management on quality, regulatory, procurement, and supply chain matters. What We’re Looking For • At least 5 years of relevant professional experience. • Several years of experience across international procurement, quality management, and regulatory affairs within healthcare products. • Very strong knowledge of the EU Medical Device Regulation (MDR), IVDR, and other relevant regulations for medical devices and healthcare products. • Experience establishing and optimizing supply chain processes and inventory management systems. • Experience working with ERP systems. • Experience collaborating with international suppliers and managing intercultural business relationships. • Experience with biomarkers or within the diagnostics industry. • Strong negotiation, communication, stakeholder management, and leadership skills. • Assertiveness combined with the ability to work effectively as part of a team. • An independent, structured, solution-oriented, and hands-on approach to work. • Ability to quickly understand new concepts and independently familiarize yourself with new subject areas. • Affinity for legal and contractual documentation. • Initial experience in HR, personnel management, and leadership. • Flexibility and agility in a dynamic scale-up environment. • Ability to pragmatically design and improve processes rather than relying solely on established structures. • Excellent English skills at approximately C1 level. • German is advantageous; Russian is an additional plus. • Degree in economics or a related discipline is preferred. Key Areas of Responsibility • Quality Management Systems • Regulatory Affairs • MDR & IVDR Compliance • Procurement & Purchasing • Supply Chain Management • Inventory Management • Supplier Management • ERP Systems • Product Quality & Complaints • Cost Optimization • Team Leadership • Healthcare & Diagnostics What the Role Offers • Leadership position with direct exposure to executive management. • Broad responsibility across quality, regulatory, procurement, and supply chain functions. • Significant scope to develop and scale operational processes. • Opportunity to work within an international healthcare and diagnostics environment. • Exposure to IVDR compliance, ERP implementation, supplier strategy, inventory management, and operational development. • Hybrid working environment in Hamburg. • Flexible work-from-home arrangements. • Opportunity to contribute to the development of preventive healthcare and rapid diagnostics solutions. Hiring Process 1. Initial interview focused on professional background and motivation. 2. Technical interview covering Quality Management, Regulatory Affairs, Procurement, and Supply Chain experience. 3. Final interview with senior management. 4. Hiring decision and offer.