German Speaking Head of Quality Manager & Regulatory Affair

Location: Hamburg Germany (Hybrid / Modern office in HafenCity)

Salary:gross p.a. (Base Performance Bonus with flexibility for exceptional profiles)

Employment Type: Permanent / Full-time

We are seeking an experienced hands-on Head of Quality Management & Regulatory Affairs Purchasing & Supply Chain (m/f/d) to join Goodscare GmbH an innovative health tech scale-up based in Hamburgs HafenCity. Focused on easily accessible preventive healthcare and rapid point-of-care diagnostics we combine cutting-edge technology with targeted consumer solutions.

This is a broad high-visibility leadership role sitting on Goodscares Leadership Team and reporting directly to executive management. You will combine three major pillars of ownership: Quality & Regulatory Affairs Procurement & Supply Chain Management and Operational Scaling. If you excel at professionalizing operations without introducing bureaucratic corporate friction this is your opportunity to shape the future of preventive healthcare.

• QMS Ownership: Take overall technical responsibility for maintaining monitoring and continuously developing the Quality Management System (QMS) quality manual and compliance structures.
• Regulatory Compliance: Ensure full adherence to MDR IVDR (ranging from Class A devices to higher-risk biomarker diagnostics) and other relevant medical device regulations.
• Standards & Stakeholder Communication: Lead the internal and external communication of quality standards representing Goodscare professionally to international suppliers auditors and partners.
• Escalations & Audits: Oversee product-quality issues manage supplier escalations conduct goods inspections based on precise product specifications and resolve complaints.

• End-to-End Purchasing: Manage day-to-day procurement supplier relationships (e.g. DX365 and manufacturing partners) and inventory forecasting to ensure high product availability.
• Working Capital Optimization: Balance product availability against inventory exposure efficiently managing products with relatively short shelf lives (typically 1218 months).
• Cost & Budget Control: Monitor and optimize product material and procurement costs to safeguard corporate profit targets.
• Logistics Strategy: Evolve the future logistics setup evaluating the potential transition of warehousing and fulfillment to an external 3PL partner as the business scales.

• Process Professionalization: Streamline and scale operational workflows stabilize the existing test portfolio and support the onboarding of new diagnostic tests and suppliers.
• Systems Migration: Play a critical role in evaluating and implementing a more modern scalable ERP system.
• Team Leadership: Provide personnel leadership and mentorship for a growing operations and logistics team fostering a high-performance culture.

• Experience: 5 years of professional experience in Quality Management Regulatory Affairs and international procurement/supply chain management within healthcare medical devices or another heavily regulated environment.
• Regulatory Expertise: Thorough independent working knowledge of MDR IVDR and medical device compliance frameworks.
• Operational & Supply Chain Acumen: Proven capability to manage end-to-end forecasting inventory control and supplier negotiations.
• Systems & Tools: Practical experience with ERP systems and an aptitude for mastering new technical platforms quickly.
• Language Skills: Fließende Deutschkenntnisse (C2) in Wort und Schrift sowie exzellente Englischkenntnisse (C1 minimum). (Russischkenntnisse sind ein starkes Plus).
• Mindset: A pragmatic hands-on builder mentality with strong analytical skills high resilience and the ability to operate autonomously in a fast-paced scale-up.

• Professional background in IVD point-of-care diagnostics biomarkers or medical-device manufacturing.
• Prior experience implementing or migrating ERP systems or scaling logistics/fulfillment operations.
• Experience building or professionalizing processes within a start-up scale-up or dynamic SME environment.

• Location & Office: Based at our modern headquarters in Hamburgs HafenCity.
• Hybrid Model: Standard arrangement includes approximately 1 home-office day per week with additional flexibility evaluated case-by-case (note that this is a Hamburg-based leadership role rather than a fully remote position).

• Competitive Remuneration: Base salary of approximately 72000 p.a. supplemented by an annual performance bonus (8000) resulting in an all-in target package of around 80000 gross p.a. (Higher flexibility available for exceptional highly matching profiles).
• Strategic Impact: High entrepreneurial freedom direct reporting line to executive management and a key seat on the leadership team.
• Culture & Growth: A dynamic startup environment with short decision-making paths flexible work policies and steep professional learning curves across international healthcare markets.