Job Title

Quality & Regulatory Affairs SpecialistMedical Device / IVD | AI-Enabled Compliance Platform Fully Remote (EU time zones)Immediate Start RequiredAbout the CompanyWe are a rapidly growing, venture-backed MedTech startup developing AI-enabled solutions to modernise and simplify medical device and IVD compliance. Our technology-driven platform is designed to help innovative companies navigate global regulatory and quality requirements more efficiently, accelerating time to market for life-changing products.Founded by experienced industry leaders and technologists, we operate at the intersection of regulatory science, quality systems, and artificial intelligence in a highly collaborative, fast-paced startup environment.The OpportunityThis is a rare opportunity to join a founding-stage medical device/IVD startup and play a critical, hands-on role in both product development and client success. Reporting directly to the Head of Quality & Regulatory Affairs, you will contribute across regulatory strategy, technical documentation, quality systems, client engagement, and AI-powered tooling.This role is fully remote, requires strong English communication skills, and is intended for candidates who can start immediately.Key ResponsibilitiesProvide expert regulatory, clinical, and quality guidance on technical documentation generated using internal compliance toolsPrepare regulatory submission packages and respond to authority or Notified Body questions during evaluation periodsSupport client engagements from onboarding through development, submission, and post-market activities, under senior leadership guidanceCollaborate closely with executive leadership and engineering teams to enhance quality systems, eQMS functionality, and AI-enabled regulatory toolsDevelop clear, user-friendly written and video guidance to support clients throughout their regulatory journeyContribute to the development, validation, and continuous improvement of new regulatory and quality solutionsSupport day-to-day quality and regulatory operations in a growing startup environmentMonitor and interpret changes in global medical device and IVD regulations and emerging regulatory trendsOptionally perform detailed reviews of client technical documentationRequired QualificationsBachelor’s degree in engineering, life sciences, or a related discipline2–6 years of hands-on experience in Regulatory Affairs and/or Clinical Affairs within the medical device or IVD industryDirect experience working in a startup or early-stage medical device / IVD company (required)Hands-on experience authoring technical documentation (e.g., Clinical Evaluation Reports) for EU submissionsSolid working knowledge of EU MDR (2017/745)Working knowledge of key standards and guidance, including:ISO 13485ISO 14971IEC 62304MDCG, IMDRF, and FDA guidance documentsFluent written and spoken English (required)Strong communication skills and a customer-centric mindsetProven ability to work independently in a fast-paced, evolving startup environmentWillingness to work flexible hours to support clients across multiple time zonesBonus ExperienceFamiliarity with US FDA medical device regulations (21 CFR)Experience with Software as a Medical Device (SaMD) and/or hardware medical devicesBroader quality systems exposure (CAPA, PMS, vigilance, audits)Experience with Notified Body audits or conformity assessmentsFamiliarity with FDA Q-Submissions, 510(k), PMA, and De Novo pathwaysExperience working with or prompt-engineering AI Large Language Models (LLMs)What We OfferCompetitive full-time salaryEquity participationFully remote work environmentHigh-impact role with visibility across leadership, product, and clientsOpportunity to shape the future of regulatory and quality technology from the ground upApply now for immediate consideration. This role is actively hiring with a fast interview and decision process.