Regulatory & Quality Specialist at Klaris - AI-driven MedTech compliance startup

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.

• 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.

• 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.

• 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.