Head of Ops (m/w/d) – Diagnostics | Hamburg, Hybrid

The opportunity

Our client is an established Hamburg company that has shifted its focus fully into diagnostics. It handles the global commercialisation of a professional point-of-care platform for rapid blood testing, an open system that reads tests from several manufacturers and is used by doctors, pharmacists and practitioners. The German launch is a year behind them, hundreds of sites are already onboarded, and international distribution has begun. Around 20 people, privately backed, and scaling.

They are hiring a Head of Quality Management & Regulatory Affairs, Purchasing & Supply Chain to make sure quality, regulatory, procurement and operational structures keep pace with commercial growth. The brief is to professionalise operations without importing corporate bureaucracy.

Why this one stands out

• Up to €100,000 per year for the right profile, plus bonus
• A seat on the leadership team with direct exposure to management
• Three functions under one remit, with scope to grow toward a Head of Operations position
• A build role, not an administer role: structures and processes are yours to shape
• Lead role in replacing the ERP system and designing the future logistics setup
• Preventive healthcare and longevity, at the point the company scales internationally
• Permanent, full-time, hybrid in Hamburg with around one home-office day a week

What you'll do

• Own and continuously improve the Quality Management System and Quality Manual, and make sure processes are followed in practice
• Maintain regulatory documentation for devices, tests and suppliers. The device is IVDR Class A; individual tests can sit in higher classes depending on the biomarker
• Lead on product-quality issues and supplier escalations, deciding with commercial stakeholders when a product is paused or recalled
• Take overall ownership of procurement and supply chain: forecasting, availability, inventory and working-capital exposure on short shelf-life products
• Manage supplier relationships and keep product cost under control
• Shape the logistics setup as the company scales, including when to move fulfilment to a 3PL
• Play a leading role in replacing the ERP system
• Lead one experienced logistics and order-processing colleague plus flexible junior support

What you bring

• Strong Quality Management and Regulatory Affairs experience in healthcare, medical devices or a comparably regulated environment. This is the hard requirement
• Supply chain and procurement experience broad enough to own forecasting, suppliers, inventory and availability
• ERP and operational process experience
• Able to work autonomously and make decisions from day one: highly structured, but pragmatic and hands-on
• Strong communicator and stakeholder manager, interculturally competent
• English C1. Around five years of relevant experience is a guideline, not a cut-off

Nice to have: IVD or diagnostics exposure, work with biomarkers or diagnostic tests, building processes in a start-up, scale-up or SME, ERP implementation or migration, scaling or outsourcing logistics, German, Russian.

Please note: this is a hands-on scale-up remit. Candidates looking for a large team or a narrow, highly specialised corporate QA/RA role are unlikely to be a fit.

Process: intro call with M2Talents, initial interview on background and motivation, technical interview on quality, regulatory and supply chain, then final interview and decision with senior management.

Apply now, or contact Mo at M2Talents for a confidential conversation.