German Speaking Head of Quality Management & Regulatory Affairs (Hybrid)

Location: Hamburg (HafenCity, Hybrid with ~1 remote day/week)

Compensation: EUR 72,000 base + EUR 8,000 KPI Bonus (negotiable for exceptional candidates)

Experience: Minimum 5 years

Language: German (fluent, C1/C2) and English (C1)

🚀 About the Role

We are looking for a strategic yet hands-on Head of Quality Management & Regulatory Affairs (m/f/d) with fluent German language skills to take overall technical responsibility for our compliance, quality management systems (QMS), procurement, and supply chain operations.

In this leadership role, you will be a key pillar of our management team in a fast-growing, innovative health-tech scale-up focused on preventive healthcare and point-of-care diagnostic solutions. You will own the operational backbone that allows us to scale commercially without introducing unnecessary corporate bureaucracy.

Over time, the role offers high strategic visibility and the potential to evolve toward a broader Head of Operations remit.

🎯 Key Responsibilities

1. Quality & Regulatory Affairs

• Own, continuously improve, and scale our existing Quality Management System (QMS), Quality Manual, and regulatory documentation.
• Ensure regulatory compliance for medical devices and tests (including MDR/IVDR requirements, varying by product class and biomarker complexity).
• Lead internal and external quality communication, representing the company professionally in German and English to suppliers, customers, and authorities.
• Oversee quality inspections of goods based on product specifications, handle product complaints, and drive critical decisions regarding product pauses or recalls when necessary.

2. Procurement & Supply Chain

• Take overall ownership of purchasing, supply chain, inventory management, and vendor relationships (including key partners like DX365).
• Manage accurate forecasting and secure optimal product availability while balancing working capital—balancing inventory limits against products with relatively short shelf lives (typically 12–18 months).
• Monitor and optimize product, material, and procurement costs to hit financial targets.
• Guide our future logistics strategy, evaluating when to transition or scale internal warehousing versus external 3PL fulfillment.

3. Leadership & Operations

• Provide personnel leadership and mentorship for a growing operations and logistics team.
• Drive operational excellence by helping professionalize processes, stabilize our diagnostic test portfolio, and onboard new tests and suppliers.
• Play a central role in replacing and migrating our current ERP system to a modern, scalable solution.
• Report directly to executive management, enjoying significant entrepreneurial freedom and short decision-making paths.

✅ What We Are Looking For

• Experience: Minimum 5 years of relevant professional experience combining international procurement, quality management, and regulatory affairs within healthcare, medical devices, or a closely regulated environment.
• Regulatory Knowledge: Deep understanding of MDR/IVDR and relevant regulatory frameworks for medical and diagnostic devices.
• Operational Skills: Strong background in supply chain optimization, inventory management, and working with ERP systems.
• Mindset: A pragmatic, hands-on, and entrepreneurial builder. You know how to structure processes without introducing heavy, rigid corporate bureaucracy.
• Autonomy: Highly independent, solution-oriented, with strong negotiation, communication, and stakeholder-management skills.
• Languages: Fluent German proficiency (C1/C2) for interacting with local authorities and German-speaking partners, alongside excellent English proficiency (C1). Russian is considered an additional plus.

Nice-to-Haves: Direct experience with IVDs, diagnostics, biomarkers, or scaling operations within a fast-growing scale-up/startup environment.

🌟 What We Offer

• Leadership Impact: A key role on our leadership team with direct reporting to executive management and high strategic visibility.
• Entrepreneurial Freedom: Total ownership over supply chain, quality, and regulatory architecture in a rapidly scaling industry.
• Modern Workspace: Attractive office located in Hamburg’s vibrant HafenCity with flexible hybrid work policies.
• Attractive Package: Competitive salary framework (EUR 72,000 – EUR 80,000 all-in target package, with flexibility for exceptional candidates) plus a steep learning curve and dynamic team culture.

Does this sound like your next challenge? We look forward to receiving your application!