Quality & Regulatory Specialist

About XENA DxXena is building the intelligence layer for surgery — an AI system that sees, plans, and guides operations, starting from endometriosis (Gynecology) surgery.Our mission: make surgery run on intelligence, not intuition.We operate across the EU and the U.S., working with leading hospitals, with a dataset of over 500 surgical cases already training our AI.Backed by Techstars Berlin, leading surgeon from the University of Freiburg, and executives from JP Morgan, Intuitive Surgical, and Roche, we are building medical software products intended to impact over millions of patients.The RoleWe’re looking for a Regulatory & Quality Specialist to support XENA’s journey in building world-class compliance and quality systems for medical software.You’ll work closely with the leadership team to design, document, and implement processes that meet international standards for medical device software — ensuring our technology safely reaches hospitals and surgeons worldwide.This is a foundational, hands-on role, ideal for someone with 2 years of operational experience in medtech, healthtech, or related fields, who’s eager to grow in regulatory and quality leadership.What You’ll DoSupport the development and maintenance of XENA’s Quality Management System (QMS)Assist in documentation and process development for ISO 13485, ISO 27001, and FDA standardsHelp prepare for internal and external audits, certifications, and inspectionsCollaborate with technical, product, and clinical teams to ensure regulatory compliance across software and data workflowsTrack and organize documentation for regulatory submissions and risk managementSupport ongoing improvements in compliance, quality, and operational readinessWhat We’re Looking ForProven track-record of getting a medical product certified 0→1 for FDA and/or CE-markBackground in biomedical engineering, quality assurance, regulatory affairs, or related fieldsFamiliarity or interest in medical device standards (ISO 13485, ISO 27001, ISO 14971, IEC 62304, HIPAA)Excellent organizational, communication, and documentation skillsHands-on, detail-oriented, and proactive in fast-moving environmentsCurious about how AI-driven medical technologies are brought to market safely and effectively1–2 years of operational experience preferred, ideally in medtech, healthtech, life sciences, or technology startupsWhy JoinBe part of a company bringing AI innovation directly into hospitalsLearn from experienced leaders in regulatory, clinical, and technical domainsContribute to real-world medical products improving patient outcomesGain mentorship and grow into a specialist or leadership role in regulatory and quality operationsFunded, high-growth environment with global exposureEquity opportunity and direct collaboration with the founding team