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Specialist Regulatory Affairs (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Engineering, Draw, Plm
Projektbeschreibung
REFERENZNUMMER:
296395/11
IHRE AUFGABEN:
-Draw up and maintain technical file documentation such as writing technical file summary reports and operating the PLM system
-Review of technical file documents such as clinical evaluation reports, risk management files, standard evaluations with respect to regulatory requirements
-Review of labelling and promotional material with regard to accuracy and consistency
IHRE QUALIFIKATIONEN:
-Profound knowledge of European medical device regulations, especially Council Directive 93/42/EEC
-Experience with the creation and maintenance of technical files according to the STED structure
-Profound experience in the European medical device industry, especially in regulatory, labelling, quality or engineering
-Outstanding German and English language skills in both verbal and written form
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
296395/11
IHRE AUFGABEN:
-Draw up and maintain technical file documentation such as writing technical file summary reports and operating the PLM system
-Review of technical file documents such as clinical evaluation reports, risk management files, standard evaluations with respect to regulatory requirements
-Review of labelling and promotional material with regard to accuracy and consistency
IHRE QUALIFIKATIONEN:
-Profound knowledge of European medical device regulations, especially Council Directive 93/42/EEC
-Experience with the creation and maintenance of technical files according to the STED structure
-Profound experience in the European medical device industry, especially in regulatory, labelling, quality or engineering
-Outstanding German and English language skills in both verbal and written form
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik