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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!
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
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges