Beschreibung
Technical Writer for combination products (m/f)
Reference: -en
Start: 08/18
Duration: 6 MM
Main tasks:
- 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
Main qualifications
- University degree in biomedical engineering, mechanical engineering, physics or similar
- Profound experience in integrated drug-device combination product development and submission
- Profound 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; 21CFR)
- 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
- English (business fluent)
- German (nice to have)
Main advantages:
- A very renowned company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Silvia Charro Lopez
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