Quality & Regulatory Affairs Lead

About 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.

The Role

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 is a senior role where you'll shape both the strategy and the culture: ensuring our products meet the highest regulatory requirements while our teams embrace quality as a driver of trust, efficiency, and impact.

What You'll Do

This role spans the full scope of quality and regulatory leadership: defining strategy, navigating global submissions, owning company-wide quality metrics, and developing the team that makes it all happen. We need someone who will:

• 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 - including 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.

What We're Looking For

• 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 - you build systems, but more importantly, you build belief.

Bonus Points For

• 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.