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Regulatory Affairs Specialist (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Engineering
Projektbeschreibung
REFERENZNUMMER:
329582/11
IHRE AUFGABEN:
-Creation and maintenance of Technical File documentation for EU Class I devices according to Council Directive 92/42/EEC
-Providing input for Clinical Evaluation Reports, Risk Management, Labelling
-Creation of Technical File Summary Reports, Essential Requirements Checklists
IHRE QUALIFIKATIONEN:
-Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
-Some experience in European Medical device industry especially with regulatory, labelling, quality or engineering
-Experience with Technical Documentation structure according to STED
-English and German spoken and written
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
329582/11
IHRE AUFGABEN:
-Creation and maintenance of Technical File documentation for EU Class I devices according to Council Directive 92/42/EEC
-Providing input for Clinical Evaluation Reports, Risk Management, Labelling
-Creation of Technical File Summary Reports, Essential Requirements Checklists
IHRE QUALIFIKATIONEN:
-Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
-Some experience in European Medical device industry especially with regulatory, labelling, quality or engineering
-Experience with Technical Documentation structure according to STED
-English and German spoken and written
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik
Hays
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Straße:
Willy-Brandt-Platz 1-3
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Ort:
68161 Mannheim, Universitätsstadt, Deutschland