Description
We are looking for a
Specialist Regulatory Affairs (m/f)
Reference: -en
Start: asap
Duration: 9 MM+
Place: in Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Organize and update technical documentations in accordance with new European and country specific regulatory standards
- Make sure that the medical devices are compliant with the product development process and with the applicable regulatory requirements (e.g. MDD 93/42/EEC)
- Evaluation of medical devices with regards to their risk potential (based on EN ISO 14971)
- Establish and support product related information (e.g. IFUs, Surgical Technique guides)
Your qualifications
- Profound practical experiences in the field of medical devices (Class l, lla and llb )
- Outstanding knowledge of regulations relevant for medical devices (MDD 93/42/EEC)
- A scientific, medical or engineering background as well as fluency in English and German
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager