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Risk Manager Medical Devices (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Design
Projektbeschreibung
REFERENZNUMMER:
338053/11
IHRE AUFGABEN:
-Ensure timely completion and quality of the assigned risk management files
-Lead specific risk management activities within projects, as agreed with project leaders
-Facilitate development and completion of risk assessments
-Work with device development team to incorporate and complete Risk Management during all design phases for new and/or product enhancements
-Ensure compliance with ISO 14971 in all development projects assigned
IHRE QUALIFIKATIONEN:
-Excellent technical writing skills (e.g. Design Controls)
-Good understanding of medical device regulations (FDA 21 CFR 820, EU Medical Device Directive) and of combination products
-Experience in Product Design and Design for Manufacturing
-Good technical knowledge of primary containers development
-General understanding of pharmaceutical development, clinical trial processes and requirements
-Fluent English skills
WEITERE QUALIFIKATIONEN:
Project manager
338053/11
IHRE AUFGABEN:
-Ensure timely completion and quality of the assigned risk management files
-Lead specific risk management activities within projects, as agreed with project leaders
-Facilitate development and completion of risk assessments
-Work with device development team to incorporate and complete Risk Management during all design phases for new and/or product enhancements
-Ensure compliance with ISO 14971 in all development projects assigned
IHRE QUALIFIKATIONEN:
-Excellent technical writing skills (e.g. Design Controls)
-Good understanding of medical device regulations (FDA 21 CFR 820, EU Medical Device Directive) and of combination products
-Experience in Product Design and Design for Manufacturing
-Good technical knowledge of primary containers development
-General understanding of pharmaceutical development, clinical trial processes and requirements
-Fluent English skills
WEITERE QUALIFIKATIONEN:
Project manager
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Medien/Design