As the first regulatory hire at Klaris, you will bridge the gap between complex medical regulations and cutting-edge AI. You'll work directly with founders and engineers to encode regulatory intelligence into our platform, transforming how MedTech companies handle submissions and quality management. This is a rare opportunity to shape a product from the ground up.
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Regulatory & Quality Specialist at Klaris
Klaris is hiring its first Regulatory & Quality Specialist to help build the AI-powered future of MedTech compliance. If you've spent years navigating MDR or FDA submissions and want to lead the transition from manual paperwork to automated intelligence, this London-based role offers a unique mix of high-impact product shaping and equity in a VC-backed startup. You'll work alongside experts from MedTech and autonomous systems to build the tools you always wished existed.
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Location
London, United Kingdom
Compensation
£55k-£70k + Equity
Company
Klaris
Role overview
AI / MedTech / Lifesciences2-5 employees
Klaris AI is an AI-powered compliance automation platform designed specifically for MedTech companies. It streamlines regulatory documentation, helps medical devices gain approvals, pass audits, and scale by identifying regulatory gaps, providing remediation guidance, and catching contradictions. Klaris automates much of the manual compliance work, allowing engineers and medical device companies to focus more on innovation and product development. The platform is built to reduce the burden of compliance, speed up time to market, and facilitate integration with agile development processes in the MedTech industry.
What you will do
- Extract requirements from regulations to build high-quality datasets that teach AI models to think like seasoned regulatory professionals.
- Partner with engineers to validate AI outputs and provide expert feedback on dossiers, 510(k)s, and technical documentation.
- Act as a subject matter expert for clients while managing Klaris's internal certifications such as ISO 27001 and IEC 62304.
Who this is a fit for
- Has 4+ years of experience in MedTech regulatory or quality roles, with a proven track record of authoring EU MDR dossiers or FDA 510(k) submissions.
- Possesses hands-on experience implementing and maintaining ISO 13485 Quality Management Systems within a fast-paced or evolving environment.
- Demonstrates an "AI-native" mindset, capable of explaining complex standards to technical teams and using technology as a force multiplier for compliance tasks.
Why this role is remarkable
- Be the founding regulatory voice in a startup backed by expert investors including Meridian Health Ventures, Antler, Vento Ventures, and industry-leading angels.
- Influence the development of AI tools designed to eliminate the manual pain of compliance, moving beyond digitizing the status quo to reinventing regulatory workflows.
- Work alongside a high-caliber team including a CEO with a decade of MedTech experience and a CTO with a PhD in safe AI systems.
How Jack & Jill work together
I get to know what you’re great at, then find roles you’d never find yourself.Ok, I'll go first. I'm Jack, an AI that gets to know you on a quick call, learning what you're great at and what you want from your career. Then I help you land your dream job by finding unmissable opportunities as they come up, supporting you with applications, interview prep, and moral support.
I recruit from Jack’s network and make the intro when I spot a great match.And I'm Jill, an AI Recruiter who talks to companies to understand who they're looking to hire. Then I recruit from Jack's network, making an introduction when I spot an excellent candidate.
Jack gets to know what you're great at and what you want next, then searches 15 million jobs daily and helps you discover roles at companies like this.
Meet Jack
What happens next?
Jack’s an AI agent for job searching and career coaching. He works for you.
Jill is the AI recruiter working for the company. She recruits from Jack’s network.
If your profile’s a match and Klaris wants to meet, Jill will make the intro. In the meantime, Jack will send you excellent alternatives.