Beschreibung
Projekt Nr.: A4118Funktion Regulatory Affairs Manager (contract)
Branche Dienstleistungsunternehmen
Pensum 100%
Arbeitsort Zug
Antrittstermin ab sofort
Dauer 12 Monate mit Option
Anzahl Stellen 1
Stellenbeschreibung
https://www.ghrgroup.ch/projekt-details/orderNr/A4118.html
Für unseren Kunden suchen wir einen sehr erfahrenen Regulatory Affairs Manager mit den Aufgaben wie:
Hauptaufgaben:
As Regulatory Affairs Manager, your responsibilities include (but are not limited to):
Prepare worldwide product registration and support affiliates and the site of Zug in the area regulatory submissions for Blood Gas and Electrolytes systems (instruments, reagents and sensors)
Support the transfer of systems from Graz to Zug
Consult and actively support the R&D project teams during the development of new products and the product life cycle
Strategic alignment and networking with Quality and other Regulatory Submission teams in Zug with respect to system strategies
Ensure conformity evaluation including compilation of the conformity declaration for new and existing products
Administration of product declarations, certificates and other similar documents
Muss-Kriterien:
University degree (e.g. law, engineering or biology) with further education in Regulatory Affairs
Minimum 3 years of experience in Regulatory Submissions of In Vitro Diagnostics
Experience in the regulatory framework for In Vitro Diagnostic Medical Devices consisting the IVD Directives or AIMD know-how
Excellent negotiation skills (e.g. with authorities)
Strong teamplayer with resilience and high self-esteem
Experiences with Medical Device directives, like MDD 93/42/EEC, IVDD 98/79/ EC, AIMD 90/385/EEC
Diverse Tätigkeiten gemäss Projektleiter.
Sprachen
Sprache mündlich schriftlich Priorität
Englisch sehr gut sehr gut ein Muss
Deutsch gut gut von Vorteil
Wir freuen uns auf Ihre Bewerbung
André van Sprundel
CEO
GHR Global Human Resources AG
Blegistrasse 13
CH-6340 Baar / ZG
Tel:
Direktnr:
Fax:
E-Mail:
Web: www.ghrgroup.ch
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