Quality & Regulatory Affairs Lead

Join to apply for the Quality & Regulatory Affairs Lead role at Sava.

All the health information we need is within us. Just below the skin. SAVA is redefining the way people interact with their health by developing the most advanced biosensing technology science has to offer, capable of accessing bodily information in a painless, real‑time and affordable way.

At SAVA, we’re building next‑generation biosensors that demand not only bold innovation but also rigorous discipline. As Quality & Regulatory Affairs Lead, you’ll set the standard for how quality and compliance enable us to grow responsibly and sustainably. This senior role shapes both strategy and culture, ensuring our products meet the highest regulatory requirements while teams embrace quality as a driver of trust, efficiency, and impact.

• 
  
• Define and lead SAVA’s Quality Management System (QMS), ensuring alignment with ISO 13485, FDA, MDR, and other applicable standards.
  
• Translate complex regulatory requirements into simple, clear processes that empower teams to move fast and right.
  
• Champion a company‑wide culture of quality—where doing things properly is the default, not the exception.
  
• Develop and execute our global regulatory strategy (FDA, CE, UKCA, RED, etc.), managing submissions and ongoing compliance.
  
• Establish and monitor company‑wide quality metrics—manufacturing performance, supplier quality, design controls, CAPA, training, and post‑market surveillance.
  
• Present clear, actionable insights to the leadership team and Board to drive decision‑making and continuous improvement.
  
• Build a system of accountability where metrics aren’t just tracked—they’re used to raise standards across the company.
  
• Partner with suppliers to ensure materials and processes meet our standards.
  
• Build and mentor a high‑performing Quality & Regulatory team.
  

• 
  
• Executive experience leading Quality and Regulatory functions in a medtech, biotech, or highly regulated hardware environment.
  
• Deep knowledge of ISO 13485, FDA 21 CFR 820, EU MDR/IVDR, and global regulatory pathways.
  
• A track record of building and scaling QMS across R&D and manufacturing.
  
• Strong analytical skills, with experience establishing and using quality metrics to drive decisions.
  
• Leadership style that is clear, pragmatic, and inspiring—building systems and belief.
  

• 
  
• Experience with continuous glucose monitoring (CGM) or similar device technologies.
  
• Background in both hardware and software‑based product compliance.
  
• Familiarity with start‑up or scale‑up company dynamics.