Responsibilities- Manage product release activities, evaluating technical and documental compliance according to Technical Direction guidelines- Participate in the configuration of systems related to product release- Coordinate communications with Notified Bodies, reference laboratories and related stakeholders- Manage documentation storage, control and retrieval, including externally archived documentation- Handle document management quality notifications, ensuring proper tracking and workflow- Approve quality notifications after evaluating their impact on batch release and product status- Monitor the status of materials affected by quality notifications- Coordinate communications with Health Authorities (e.G., AEMPS) regarding import/export activities- Issue and manage authorizations and official letters required for import/export processes- Ensure compliance with applicable regulations such as ISO 13485,



IVDR and MDSAP- Act as internal auditor and participate in supplier audits- Participate in continuous improvement of the Quality Management System.Requirements- Bachelor's degree in Engineering, Health Sciences or similar- At least 3 years of experience in Quality Assurance or Regulatory Affairs- Experience in regulated environments under ISO13485 and/or IVDR- Experience in team management- Experience in audits- Excellent communication skills- Cross-functional and collaborative work with multiple departments- Attention to detail and compliance- Analytical ability and technical judgement in impact assessments- English level is C1.Certifications & Qualifications- Bachelor's Degree in Engineering- Bachelor's Degree in Health Sciences#J-18808-Ljbffr

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