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