We are seeking an experienced QA/RA Manager to lead the quality and regulatory affairs team for Class II and Class III medical devices. The role requires managing and maintaining the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR 820, and EU MDR 2017/745. The manager will oversee regulatory submissions including 510(k), CE marking, and international registrations, as well as CAPA processes, audits, management reviews, post-market surveillance, and complaint handling. Coordination with R&D, manufacturing, and clinical teams to ensure design control compliance is essential. The candidate will train and mentor team members and interface with notified bodies and regulatory authorities. The role requires a BSc in Biomedical Engineering, Life Sciences, or a related field, with a minimum of 7 years of QA/RA experience in the medical device industry (5+ years considered if strong Class III experience) and at least 3 years in a management role. Deep knowledge of ISO 13485, FDA QSR (21 CFR 820), EU MDR 2017/745, and risk management (ISO 14971) is mandatory. Fluency in English is required, Hebrew is an advantage. The position involves travel twice weekly between the Yokneam and Tel Aviv offices. Experience with active implantable devices is a significant plus. The salary range is flexible for the right candidate.