Technical Writer – Combination Products (m/w) – Freelance – geschlossen

  • Position zu besetzen ab 1. August 2018
  • Permanent-ID OCR-FL-2018-1126
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 2x
  • Kategorien Freelance/Contracting, Pharma

Aufgaben

  • Review supplier’s and internal development documentation
  • Identify documentation gaps of DHF content and ensure good documentation practice are upheld
  • Adapt existing/ create missing project design and development documentation as part of the DHF with respect to supplier’s Quality Management System
  • Elaborate and maintain Essential Requirements Checklist (MDD), transition to Safety and Performance Requirements checklist (MDR)
  • Support creation of Technical Dossier for product approval
  • Active participation to Regulatory function team meetings, Project team/Quality/Development meetings, Supplier audits as required
  • Some EU travel should be assumed to enable alignment with supplier documentation

Anforderungen

  • University degree in biomedical engineering, mechanical engineering, physics or similar.
  • 5-10 years of experience in integrated drug-device combination product development and submission
  • 5-10 years of experience in product development project documentation according to international standards for Medical Devices / Combination Products
  • Experience with working in a cross-functional, complex project environment
  • Strong national and international standards knowledge for combination products (MDD/MDR; ISO 13485; ISO 14971; IEC 62366; 21CFR4/210/211/820)
  • Strong knowledge of applicable EU/US guidelines in the field of drug-device combination products
  • Strong knowledge of EU and US regulatory requirements for drug-device combination products (cGMP)
  • English – business fluent

Zusätzliche Informationen

Standort: Hamburg

Projektbeginn: August 2018

Projektlaufzeit: 31.01.2019
(Verlängerungsoption 3-6 Monate)

Verfügbarkeit: Vollzeit (120 Tage)

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