Specialist Regulatory Affairs (m/f)

the Bern region  ‐ Onsite
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Description


We are looking for a
Specialist Regulatory Affairs (m/f)

Reference: -en
Start: asap
Duration: 3 MM+
Place: in the Bern region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen

Your tasks:
  • 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


Your qualifications
  • 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



Skills:
- Regulatory affairs manager


Keywords: Regulatory Affairs Manager
Start date
ASAP
Duration
3 MM+
(extension possible)
From
Hays AG
Published at
03.02.2016
Contact person:
Kerstin Werner
Project ID:
1063399
Contract type
Freelance
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