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 System Ensure compliance with EU MDR 2017/745 and applicable medical device regulations Manage Technical Documentation, regulatory changes and product compliance Lead PMS, vigilance, risk management, CAPA,



non-conformities and change control Coordinate audits and interactions with Notified Bodies and regulatory authorities Support regulatory requirements for international market expansion Advise Product and R&D; teams on regulatory implications of new features and product changes Review marketing claims and commercial materials from a regulatory perspective Support the company in navigating the regulatory requirements associated with software and AI WHAT WE ARE LOOKING FOR? • 5+ years of experience in QA/RA within Medical Devices, Sa MD, Digital Health or a similar regulated environment Strong knowledge of MDR 2017/745, ISO 13485 and ISO 14971 Experience with QMS, PMS, risk management, CAPA and technical documentation Experience working with Medical Device Software / Sa MD is highly valued Experience with Notified Bodies and audits Professional English and Fluent Spanish High level of autonomy, ownership and attention to detail Ability to work cross-functionally and translate regulatory requirements into practical business solutions Nice 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

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