Regulatory Affairs Specialist

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 are building next-generation biosensors that demand not only bold innovation but also rigorous discipline. As Regulatory Affairs Specialist, you will play a key hands‑on role in ensuring our devices meet global regulatory requirements as we prepare for pivotal trials, CA/CE marking, and European launch. You will help translate regulatory frameworks into practical and scalable processes that enable fast, compliant development. This is an ideal role for someone with experience in medical devices, looking to deepen their regulatory mastery while contributing directly to a transformative health technology.

What You’ll Do

• Support the planning and execution of global regulatory pathways (FDA, CE, UKCA, etc.) across both hardware and software components.
• Prepare and support regulatory submissions including gathering evidence, compiling documentation, and coordinating cross‑functional inputs.
• Help translate regulatory requirements into clear processes, templates, and guidance that empower R&D, clinical, and manufacturing teams.
• Monitor standards and regulatory updates, ensuring SAVA remains ahead of evolving requirements.
• Contribute to Design History Files (DHF), risk management activities, and design control documentation while ensuring ongoing QMS compliance.
• Collaborate with cross‑functional teams to support audits, inspections, and internal QMS assessments.
• Assist in tracking regulatory performance metrics and identifying opportunities for improvement.
• Work with suppliers and internal manufacturing teams to ensure materials, components, and processes adhere to regulatory expectations.

What We’re Looking For

• 3–6 years of experience in regulatory affairs within medical devices, biotech, diagnostics.
• Solid working knowledge of global device regulatory pathways (CE/EU MDR, UKCA, FDA) and quality system regulations (ISO 13485, FDA 21 CFR 820).
• Experience preparing and maintaining regulatory submissions and technical documentation.
• Strong organisational and analytical skills, with a detail‑driven approach to documentation.
• Able to communicate regulatory concepts clearly and work effectively across engineering, clinical, and manufacturing teams.

Bonus Points For

• Experience in wearable medical devices, biosensing, or continuous glucose monitoring (CGM)‑like technologies.
• Exposure to software as a medical device (SaMD) or integrated hardware–software product development.
• Experience in start‑up or scale‑up environments, especially during pre‑market clinical and regulatory milestones.

Why SAVA?

This is a high‑ownership, high‑responsibility role in a company that’s building something complex, meaningful, and fast. The expectations are high, the learning curve is steep, and the work is often messy ― but the impact is real. We don’t have room for egos or passengers. What we do have is a team of thoughtful, driven, and mission‑aligned people who are committed to building something better ― and doing it with urgency and integrity.

Location

London, England, United Kingdom

Employment Type

Full‑time

Seniority Level

Mid‑Senior level