ppWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. /p pbWe believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us outstanding. /b /p h3Responsibilities /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) and Pharmacy Inspection 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 h3Qualifications /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 ISO 13485 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 C1. /li /ul h3Benefits /h3 pFlexible schedule: Monday‑Thursday 7‑10 to 16‑19h and Friday 8‑15h (with the same adaptable start time). /p pContract of Employment: Permanent. /p pLocation: Parets del Vallès, Spain. /p pGrifols is an equal opportunity employer. /p pWe believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help. /p pInformation about Grifols is available at /p /p #J-18808-Ljbffr