ResponsibilitiesManage product release activities, evaluating technical and documental compliance according to Technical Direction guidelinesParticipate in the configuration of systems related to product releaseCoordinate communications with Notified Bodies, reference laboratories and related stakeholdersManage documentation storage, control and retrieval, including externally archived documentationHandle document management quality notifications, ensuring proper tracking and workflowApprove quality notifications after evaluating their impact on batch release and product statusMonitor the status of materials affected by quality notificationsCoordinate communications with Health Authorities (e.G., AEMPS) regarding import/export activitiesIssue and manage authorizations and official letters required for import/export processesEnsure compliance with applicable regulations such as ISO 13485,



IVDR and MDSAPAct as internal auditor and participate in supplier auditsParticipate in continuous improvement of the Quality Management System.RequirementsBachelor's degree in Engineering, Health Sciences or similarAt least 3 years of experience in Quality Assurance or Regulatory AffairsExperience in regulated environments under ISO13485 and/or IVDRExperience in team managementExperience in auditsExcellent communication skillsCross-functional and collaborative work with multiple departmentsAttention to detail and complianceAnalytical ability and technical judgement in impact assessmentsEnglish level is C1.Certifications & QualificationsBachelor's Degree in EngineeringBachelor's Degree in Health Sciences#J-18808-Ljbffr

📌 Qa Product Release Section Manager (Madrid)
🏢 Jobtailor
📍 Madrid