ph3Responsibilities /h3 ul liManage product release activities, evaluating technical and documental compliance according to Technical Direction guidelines /li liParticipate in the configuration of systems related to product release /li liCoordinate communications with Notified Bodies, reference laboratories and related stakeholders /li liManage documentation storage, control and retrieval, including externally archived documentation /li liHandle document management quality notifications, ensuring proper tracking and workflow /li liApprove quality notifications after evaluating their impact on batch release and product status /li liMonitor the status of materials affected by quality notifications /li liCoordinate communications with Health Authorities (e.g., AEMPS) regarding import/export activities /li liIssue and manage authorizations and official letters required for import/export processes /li liEnsure compliance with applicable regulations such as ISO 13485,
IVDR and MDSAP /li liAct as internal auditor and participate in supplier audits /li liParticipate in continuous improvement of the Quality Management System. /li /ul h3Requirements /h3 ul liBachelor's degree in Engineering, Health Sciences or similar /li liAt least 3 years of experience in Quality Assurance or Regulatory Affairs /li liExperience in regulated environments under ISO13485 and/or IVDR /li liExperience in team management /li liExperience in audits /li liExcellent communication skills /li liCross-functional and collaborative work with multiple departments /li liAttention to detail and compliance /li liAnalytical ability and technical judgement in impact assessments /li liEnglish level is C1. /li /ul h3Certifications Qualifications /h3 ul liBachelor's Degree in Engineering /li liBachelor's Degree in Health Sciences /li /ul /p #J-18808-Ljbffr