Head of Quality Management & Regulatory Affairs in Hamburg

Head of Quality Management & Regulatory Affairs

Full-Time - Hybrid - Hamburg, Germany

Annual Compensation: €70,000-€80,000

About the Role

A healthcare and diagnostics scale-up is seeking a senior professional to lead quality management, regulatory affairs, procurement, and supply chain operations.

This leadership role combines 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 and international suppliers while helping build scalable operational processes in a dynamic healthcare environment.

The ideal candidate brings at least five years of relevant experience across international procurement, quality management, and regulatory affairs for healthcare products, along with a strong understanding of medical device and diagnostic regulations.

What You'll Do

• Take overall technical responsibility for compliance with and continued 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, inventory levels, and efficient use of working capital.

• Manage and develop a growing team across relevant operational functions.

• Monitor and optimize product, material, and procurement costs to support profitability targets.

• Develop and optimize procurement, supply chain, inventory management, 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 coordination with sales and manufacturing partners.

• Conduct ongoing quality inspections against defined product specifications.

• Manage, investigate, and resolve product complaints.

• Further develop, implement, maintain, monitor, and optimize the QMS.

• Work directly with senior management on quality, regulatory, procurement, and supply chain priorities.

What We're Looking For

• At least 5 years of relevant professional experience.

• Several years of experience in international procurement, quality management, and regulatory affairs within healthcare products.

• Strong knowledge of the EU Medical Device Regulation (MDR), In Vitro Diagnostic Medical Devices Regulation (IVDR), and other relevant healthcare product regulations.

• Experience establishing and optimizing supply chain processes and inventory management systems.

• Experience working with ERP systems.

• Experience collaborating with international suppliers and managing cross-cultural business relationships.

• Experience with biomarkers or within the diagnostics industry.

• Strong negotiation, communication, leadership, and stakeholder management skills.

• Ability to work independently with a structured, solution-oriented, and hands-on approach.

• Strong ability to understand legal and contractual documentation.

• Experience in team leadership and/or personnel management.

• Flexibility and agility in a fast-moving scale-up environment.

• Ability to quickly understand new products, regulations, systems, and operational requirements.

• Excellent English skills.

• German language skills are advantageous; Russian is an additional plus.

• A degree in economics or a related discipline is preferred.

Leadership & Scope

This role offers broad responsibility across:

• Quality Management

• Regulatory Affairs

• Procurement

• Supply Chain Management

• Inventory Management

• Supplier Management

• ERP Systems

• Team Leadership

• Healthcare and Diagnostics Operations

You will have direct visibility with senior management and significant responsibility for developing and scaling operational processes across an international healthcare environment.

Work Environment

• Full-time employment

• Hybrid working model

• Based in Hamburg, Germany

• Leadership position with direct reporting to senior management

• International supplier and stakeholder exposure

• Opportunity to shape quality, regulatory, procurement, and supply chain processes within a growing healthcare organization

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. Offer and hiring decision.

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