Greater Rostock Region
- Leadership of > 50 employees in Regulatory worldwide - Approval of Technical Documentation and Design Dossiers and signing of Declaration of Con-formity according to MDD/MDR, IVD/IVDR on behalf of management - Maintenance of biological and cell therapeutic medicinal products - Regulatory support of MACS GMP products for cell therapy (cytokines, antibodies, peptide pools, cell culture media and culture bags) - Manufacturing license and regulatory support of lentiviral vector - Development of regulatory strategies for ATMPs - Advanced Therapy Medicinal Products Regulation (Regulation (EC) No. 1394/2007) - Identification of regulatory requirements and management of all regulatory processes in the development, manufacturing and worldwide marketing of pharmaceuticals, medical devices, RUO & MACS GMP devices and other regulated products of Miltenyi Biotec B.V. & Co. KG
weltweite Zulassung von Medizinprodukten und Arzneimitteln