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Regulatory Affairs Specialist

Eingestellt von Randstad (Schweiz) AG

Gesuchte Skills: Support, Client, Network

Projektbeschreibung

Regulatory Affairs Specialist

Randstad Professionals are one of the leading recruitment companies in Switzerland and with a dedicated IT contracting team in Zurich. We are excited to help you in your search. We focus on finding the best contracts for the best contractors.

We are looking for a Regulatory Affairs Specialist for our client based in Solothurn.

The responsibilities of this position include:

Support the internal Regulatory Affairs group in creation and maintenance of Technical File documentation according to Council Directive 92/42/EEC:
- Creation, review and maintenance of regulatory related technical documentation
- Capturing and verification of regulatory product characteristics to support logistic and supply chain efforts on a global scale
- Providing Regulatory input and support for upcoming MDR revision

What we require from the candidate:
- Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
- Knowledge of FDA regulations and registration requirements in further global markets would be an asset
- 2-3 years of experience in European Medical device industry especially with regulatory, quality or engineering
- Familiarity with Technical Documentation structure according to STED required
- Experience in projects related to Supply Chain and Logistics would be an asset
- Excellent skills in computer software such as MS Word, Excel, Powerpoint
- Strong Database skills
- Strong analytical skills and network thinking
- Excellent English spoken and written, German is an asset

We are looking forward to receiving your full application.

Good to know you!

Projektdetails

  • Einsatzort:

    Solothurn, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 month +

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Randstad (Schweiz) AG