Skane County, Sweden
Manager Regulatory Affairs at Baxter Gambro Renal
Medical Devices
Experience
Baxter Gambro Renal August 2014 - Present
Gambro November 2006 - August 2014
Manpower Sweden 1998 - 2006
Skills
Quality System, CE marking, GMP, FDA GMP, Clinical Trials, QSR, Quality Control, ISO 14971, ISO 13485, Iso 9000, Regulatory Requirements, Medical Device Directive, V&V, 21 CFR, International..., Medical Devices, Quality Auditing, Design Control, ISO, Validation, Regulatory Submissions, 21 CFR Part 11, FMEA, International..., Product Development, R&D, Quality Assurance, FDA, Change Control, Quality Management, SOP, CAPA, Regulatory Affairs, Sop, Cross-functional Team..., IEC 60601, Pharmaceutical Industry