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Regulatory Affairs Specialist (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support
Projektbeschreibung
REFERENZNUMMER:
335592/11
IHRE AUFGABEN:
-Support the internal Regulatory Affairs group in creation and maintenance of Technical File documentation
-Reviewing of Risk Management Documentation according to EN ISO 14971:2012 with respect to regulatory requirements
-Ensuring that the company's products comply with the regulations of government agencies
-Keeping up to date with a company's product range
-Developing and writing clear arguments and explanations for regulatory documentation
IHRE QUALIFIKATIONEN:
-Experience in Medical Device Regulatory
-Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
-Experience with Risk Management documentation for medical devices according to EN ISO 14971:2012
-Familiarity with Technical Documentation structure and technically versed in computer software such as MS Word, Excel, Powerpoint
-Excellent command of English and German
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
335592/11
IHRE AUFGABEN:
-Support the internal Regulatory Affairs group in creation and maintenance of Technical File documentation
-Reviewing of Risk Management Documentation according to EN ISO 14971:2012 with respect to regulatory requirements
-Ensuring that the company's products comply with the regulations of government agencies
-Keeping up to date with a company's product range
-Developing and writing clear arguments and explanations for regulatory documentation
IHRE QUALIFIKATIONEN:
-Experience in Medical Device Regulatory
-Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
-Experience with Risk Management documentation for medical devices according to EN ISO 14971:2012
-Familiarity with Technical Documentation structure and technically versed in computer software such as MS Word, Excel, Powerpoint
-Excellent command of English and German
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges
Hays
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Straße:
Willy-Brandt-Platz 1-3
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Ort:
68161 Mannheim, Universitätsstadt, Deutschland