German Speaking Head of Quality Manager & Regulatory Affair (Hybrid)

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

Salary: €70,000 – €80,000 gross p.a. (Base + Performance Bonus, with flexibility for exceptional profiles)

Employment Type: Permanent / Full-time

About The Role

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 Hamburg's 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 Goodscare's 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.

Key Responsibilities

1. Quality Management & Regulatory Affairs (QA/RA)

• 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.
  
  
  

2. Procurement & Supply Chain Management

• 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 12–18 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.
  
  
  

3. Operations & Scaling Projects

• 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.
  
  
  

Candidate Profile & Requirements

Must-Haves:

• 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.
  
  
  

Nice-to-Haves:

• 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.
  
  
  

Working Environment & Location Policy

• Location & Office: Based at our modern headquarters in Hamburg's 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).
  
  
  

Compensation & Benefits

• Competitive Remuneration: Base salary of approximately €72,000 p.a. supplemented by an annual performance bonus (:€8,000), resulting in an all-in target package of around €80,000 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.