We are supporting a fast-growing Medical Devices company that is developing innovative solutions. As the company continues to grow internationally, we are looking for a QA/RA Manager to take ownership of the Quality & Regulatory Affairs function and support the business in its next stage of expansion.WHAT WILL YOU DO?You will be the main point of contact for Quality & Regulatory Affairs, working closely with the CEO and collaborating with Product, R&D;, Clinical, Marketing and Business teams.Your responsibilities will include:Lead and maintain the ISO 13485 Quality Management SystemEnsure compliance with EU MDR 2017/745 and applicable medical device regulationsManage Technical Documentation, regulatory changes and product complianceLead PMS, vigilance, risk management, CAPA,



non-conformities and change controlCoordinate audits and interactions with Notified Bodies and regulatory authoritiesSupport regulatory requirements for international market expansionAdvise Product and R&D; teams on regulatory implications of new features and product changesReview marketing claims and commercial materials from a regulatory perspectiveSupport the company in navigating the regulatory requirements associated with software and AIWHAT WE ARE LOOKING FOR?
-

5+ years of experience in QA/RA within Medical Devices, SaMD, Digital Health or a similar regulated environmentStrong knowledge of MDR 2017/745, ISO 13485 and ISO 14971Experience with QMS, PMS, risk management, CAPA and technical documentationExperience working with Medical Device Software / SaMD is highly valuedExperience with Notified Bodies and auditsProfessional English and Fluent SpanishHigh level of autonomy, ownership and attention to detailAbility to work cross-functionally and translate regulatory requirements into practical business solutionsNice to have: IEC 62304, IEC 62366-1, GDPR, ISO 27001/ENS and international regulatory experience.WHY THIS ROLE?You will join a high-growth MD company, taking ownership of a critical f

📌 Ra&Qa (Madrid)
🏢 EMPRESA ANONIMA
📍 Madrid