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Regulatory Affairs RA Medical Device
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Support, Engineering
Projektbeschreibung
Job Title: Regulatory Affairs Specialist
Project start date: 20.02.2017
Project end date: 22.12.2017
Place of work: Solothurn
Workload/weekly working hours: 100%/40 hours
Responsibilities:
Support the internal Regulatory Affairs team in creation and maintenance of Technical File documentation for EU Class I devices according to Council Directive 92/42/EEC:
-Creation of Technical File Summary Reports, Essential Requirements Checklists, List of Applied Standards
-Reviewing of and providing input for Clinical Evaluation Reports, Risk Management, Labeling.
-Providing Regulatory input and support for upcoming MDR revision.
-Creating and Maintaining of data sets that support Technical File maintenance and sustainability.
What we require from the candidate:
-Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
-2-3 years of experience in European Medical device industry especially with regulatory, labeling, quality or engineering
-Familiarity with Technical Documentation structure according to STED
Additional skills:
-Technically versed in computer software such as MS Word, Excel, Powerpoint
-Strong database skills (Access) desired
-Strong analytical skills and network thinking
-Fluent English and German spoken and written
Project start date: 20.02.2017
Project end date: 22.12.2017
Place of work: Solothurn
Workload/weekly working hours: 100%/40 hours
Responsibilities:
Support the internal Regulatory Affairs team in creation and maintenance of Technical File documentation for EU Class I devices according to Council Directive 92/42/EEC:
-Creation of Technical File Summary Reports, Essential Requirements Checklists, List of Applied Standards
-Reviewing of and providing input for Clinical Evaluation Reports, Risk Management, Labeling.
-Providing Regulatory input and support for upcoming MDR revision.
-Creating and Maintaining of data sets that support Technical File maintenance and sustainability.
What we require from the candidate:
-Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
-2-3 years of experience in European Medical device industry especially with regulatory, labeling, quality or engineering
-Familiarity with Technical Documentation structure according to STED
Additional skills:
-Technically versed in computer software such as MS Word, Excel, Powerpoint
-Strong database skills (Access) desired
-Strong analytical skills and network thinking
-Fluent English and German spoken and written
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges