ID EXISTS
POS 5195
Status 7
DJM 1

Regulatory Affairs Manager

Beschreibung: For one of our medical devices clients in Switzerland near Zurich we are seeking freelance support as Regulatory Affairs Manager (M/W/D)
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Task:
  • Being responsible for regulatory aspects during the development of new VI products (regulatory strategy, applicable standards and guidelines)
  • Registration of class III devices in the CE, US, and other highly regulated countries
  • Preparation of MDR submission for class III combination products
  • Coordinating and submitting deficiency responses to relevant certification bodies and country authorities 
  • Maintaining regulatory documentation up to date for worldwide regulatory purposes
  • Worldwide assessment of changes and support production lifecycles activities 
  • Establishing and updating internal procedures to enable up to date and consistent output, as well as efficient workflow within the department and project team
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Qualification:
  • Start: asap // Duration: 6 months // Capacity: 4-5 days/week
  • University degree in natural science, pharmacy, pharmacology, medicine or engineering
  • At least 4 years of experience with registrations of class 3 medical devices including drug-device combination products in highly regulated countries, particularly in the CE region and the USA.
  • Excellent knowledge of the applicable medical device regulations in the countries mentioned above, including current developments (MDR)
  • Experience in project management
  • Literate in Microsoft Office applications; SAP knowledge is an advantage
  • Independent, reliable and communicative personality who can deliver high-quality work even under pressure and handle several projects simultaneously
  • Fluency in the English language mandatory, German and any other language an advantage
Bemerkungen: WANTED: Regulatory Affairs Manager (M/F/D). Please contact +49 89 1890998 21 or pascal.freyer@k-recruiting.com Skills: ECP MedTech-Regulatory Affairs, English, German, Regulatory Affairs
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Interesse geweckt?
Auf geht's!
Beginn: asap
Laufzeit: 6 Monate +
Einsatzort: Near Zurich and remote
WhatsApp-Service: Mit WhatsApp zum nächsten Projekt!

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