Regulatory & Quality Specialist

Join us as our first regulatory hire. Build the tools you wish existed, help every RA team stuck in the same pain. You have spent years navigating regulatory complexities. You know where the pains are. Now imagine building the tools you wish existed, an AI that actually understands what auditors look for, what submissions need, what "compliant" really means.

This is rare: a chance to shape a product from the inside, with founders who have lived the problem and investors who get the space.

About Us: Compliance in MedTech is complex, manual, and error-prone, but if done correctly can be a differentiator, a moat, and a strategic endeavour. We are a startup in London transforming how MedTech companies do compliance helping teams can move faster with confidence. Backed by Meridian Health Ventures, Antler, Vento Ventures, and angels who are regulatory experts and MedTech executives (many of whom use our product).

The Role: You will be the regulatory expert working alongside our AI engineers. Your job: teach them what "great" looks like.

• Help AI development: extract requirements from regulations, validate AI outputs, build datasets that teach the system to think like a regulatory professional.
• Shape the product: research client and industry pain points, review regulatory updates, identify opportunities for improvement.
• Create content: write blog posts, guides for clients to decode new regulations and establish Klaris's voice in the market.
• Work with clients: support regulatory teams, understand their real-world workflows, and translate insights into product improvements.
• Maintain internal compliance: help Klaris achieve and maintain certifications (IEC 62304, ISO 27001).

You will work closely with our regulatory advisors with a combined 70 years of experience in the field. They will provide strategic guidance and specific knowledge; you will drive daily execution.

What We Are Looking For: 5-7 years in MedTech regulatory and/or quality. You have authored submissions, built QMS documentation, or led compliance initiatives. You have a track record of establishing or adapting regulatory processes to achieve better outcomes, reduced timelines, improved quality, and successful certifications. You think about how tech can enhance and change existing regulatory workflows, not just digitise the status quo.

Think in principles, not just procedures. You should be able to read a regulation and explain what it actually requires, not just quote it. High agency, AI-native. You do not need startup experience, but comfort with incomplete information, and genuine excitement about building something new. You use AI as a multiplier: parsing standards, building datasets, cross-referencing faster than any team could manually.

Core Skills:

• Regulatory submissions: You have authored (not just contributed to) an EU MDR dossier, FDA 510(k)s, or similar.
• In-depth regulatory or quality: You have owned one or multiple pieces of the compliance machine (e.g., clinical evaluation, post-market surveillance, or change management).
• Hands-on QMS experience: You have implemented and maintained an ISO 13485 quality system.
• Clear communication: You can explain complex requirements to engineers and product people without drowning them in jargon.

What we offer:

• Competitive compensation: base salary + real equity, with flexibility to adjust the cash/equity mix for more senior candidates.
• Enough time off: 25 days + UK bank holidays.
• Flexible London Office: We value in-person collaboration and would love you in our Aldgate East office regularly, especially initially. But we are also parent-friendly and offer genuine flexibility.
• Health & Pension: Health insurance and pension schemes matching.

Target start: As soon as possible. 30-min chat with CEO, 1h-1.5h technical deep-dive, 45-min lunch or coffee with founders, Reference Checks + Offer.

Klaris is an equal opportunity employer. We welcome applications regardless of race, religion, gender, sexual orientation, age, disability, or background.