Head of Quality & Regulatory

📍 Location: Europe💼 Title: Head of Quality and Regulatory✉️ Contact: Sam - sam@elemed.euAI-powered medical imaging is moving fast enough that quality and regulatory functions have to move with it. Do you have the technical depth to embed compliance into an AI/ML development lifecycle, and the leadership instinct to build a team that makes it work at scale? The CompanyThis is a company operating at the sharper end of Clinical AI, building software that helps detect and manage complex screening programmes across hundreds of sites worldwide. Their portfolio spans enterprise imaging informatics and population health solutions, all connected through a cloud-native platform that puts AI into the hands of every person in the radiology workflow. The business sits within a larger, stable, and internationally active organisation, which means you are joining a well-resourced environment with serious commercial backing, not a pre-revenue startup. Multiple business units, a strong regulatory track record including recent CE Marks and FDA 510(k) clearances, and an expanding global footprint give this organisation genuine substance. The culture here is collaborative and technically serious. The people building these products care about clinical evidence, real-world performance, and getting the science right. Quality is not an afterthought in that kind of environment, and that makes a difference to the kind of work you will do. The OpportunityGrowing a Clinical AI portfolio across EU MDR, FDA, and international markets puts you in a position where both depth and breadth matter. As Head of Quality and Regulatory, you will own the full quality, regulatory, and compliance remit for the Clinical AI business unit, working directly with R&D, Product, and Clinical teams to build compliance into the development process rather than bolting it on at the end. This is a leadership role with scope to develop. You will manage and grow the QRC team, setting the capability roadmap alongside the product roadmap. There is real space to redesign how quality and regulatory work gets done, simplifying processes, automating where it makes sense, and building a lean compliance culture that supports fast product iteration without cutting corners. The successful applicant will also serve on the business unit leadership team, which means your voice carries on product strategy and market expansion decisions. If you have opinions about how AI/ML compliance should work in practice, and the track record to back them up, this is an environment where those opinions will land. What You'll Be DoingEmbed design controls, IEC 62304 software lifecycle processes, ISO 14971 risk management, and IEC 62366 usability engineering directly into Agile development workflows in close co-operation with R&D and Product teams.Define and continuously improve quality processes specific to AI/ML development, including data management, model validation, performance monitoring, and change management for learning systems aligned to GMLP principles.Own the preparation and submission of EU MDR technical files, FDA 510(k) submissions, and international regulatory filings, and manage any queries or challenges from regulatory authorities.Lead all interactions with notified bodies, the FDA, and European Competent Authorities, serving as the primary external interface for the business unit.Monitor product quality KPIs across CAPA, complaints, and post-market signals, and drive corrective and preventive actions through to closure.Oversee the compilation and maintenance of technical documentation and Design History Files required for CE marking and FDA submissions.Build and develop the QRC team through active mentoring, performance management, and succession planning, scaling capability in line with the product roadmap.Advise the business unit leadership team on regulatory strategy, market expansion sequencing, and product compliance risk.Champion a lean approach to compliance across the organisation, identifying and eliminating non-value-adding processes and promoting shared quality ownership in cross-functional teams.What We're Looking For10+ years in Quality and/or Regulatory Affairs within the medical device or Software as a Medical Device industry, with meaningful experience on AI/ML-based products.Demonstrated track record of leading and developing QA/RA teams, including direct reports, ideally through a period of growth or organisational change.Hands-on experience with design controls and software development compliance under IEC 62304, ISO 14971, and IEC 62366 in an Agile environment.Direct experience leading EU MDR technical documentation and FDA 510(k) submissions, including interactions with notified bodies and the FDA. How to applyTo apply, send your CV to sam@elemed.eu. About ElemedElemed is a specialist consultancy and talent management agency focused exclusively on the MedTech, Digital Health, Diagnostics and Pharma industries. We help healthcare companies bring products to market faster by combining technical consulting, strategic hiring and professional development. Want career inspiration? Listen to our executive podcast here. We're at the very start of this process- interviews expected to commence mid October