ID EXISTS
POS 2982
Status 5
DJM 1

Medical Device Project Leader

Beschreibung: For one of our Swiss Pharma clients we are seeking temporary support as: Medical Device Project Leader (M/F/*)
Tasks:
  • Leading the definition of product requirements for packaging, medical devices, delivery systems (e.g. combination products)
  • Leading the collaboration with internal/external development partners
  • Evaluating technical solutions
  • Supporting and coordinating the manufacturing of clinical material and the production scale up
  • Supporting cross functional project teams in the development, review and submission of regulatory dossiers
  • Managing Human Factors Engineering activities
Qualifications:
  • Start: asap / Duration: 12 month / Capacity: 40 h/week / Location: Greater Basel
  • Must haves:
  • Degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education (ideally a relevant degree in engineering and at least 7 years’ experience in leading device development technical teams in a similar area)
  • Experience in Human Factors Engineering, risk management and clinical studies processes and requirements
  • Planning and monitoring of design verification activities (in-house)
  • Ensuring and Transfer of Design History File to production
  • Profound knowledge of Medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation)
  • Writing of technical documentation of drug/device combination products and medical devices, including Design Control process (QA and GMP aspects)
  • Language Experience: English (business fluent)
Bemerkungen: WANTED: Medical Device Project Leader (M/F/*). Please contact: +49 89 18 90 998 58 oder anna.eigen@k-recruiting.com Skills: English, German, Medical Devices, Packaging, QA (Quality Assurance), Qualification & Validation, Risk Management
Interesse geweckt?
Auf geht's!
Beginn: asap
Laufzeit: 12 months +
Einsatzort: Basel, Switzerland
WhatsApp-Service: Mit WhatsApp zum nächsten Projekt!

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