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Medical Device Technical Expert (m/f) Job ID: 10440

Ihre Aufgaben
  • Run and lead technical development activities for medical devices e.g. Autoinjector, Safety syringes
  • Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems. Author and Reviewer of DHF documents. Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects
  • Ensure device design development in compliance with the regulations and delivered at a high quality
  • Consult on the development of medical devices and combination productsSupport DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions
Ihr Anforderungsprofil
  • Excellent technical writing skills (e.g., Design Controls)
  • Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)and of combination products (US)
  • Experience in Product Design and Design for Manufacturing
  • Good technical knowledge of primary containers development
  • Good technical knowledge of autoinjector development
  • Good communication skills
  • General understanding of Human Factors Engineering and Risk management
  • General understanding of clinical trial processes and requirements
  • General understanding of pharmaceutical development
Auf Anfrage
Auf Anfrage
Dominik Reinelt
Fon +41 41 510 04 90
Mobil +49 152 338 598 09
Dominik Reinelt
Fon +41 41 510 04 90
Mobile +49 152 338 598 09
Mail dominik.reinelt@theentourage.ch
Betreff Bewerbung für Job ID 10440 auf theentourage.de