Beschreibung
Regulatory Reviewer for Changes and Technical Files
The responsibilities of this position include:
Acting as a reviewer of changes conducted for marketed medical devices in order to:
- assess and document completeness of change assessment with focus on Regulatory aspects
- identify and document deficiencies
Contributing to completion of Technical Files by:
- Reviewing of Technical File content for completeness
- Interpreting of test data (mechanical, shelf life, sterility, reprocessing, etc ) for allocation to corresponding articles.
- Supporting of non-clinical and clinical literature searches and interpretation.
What we require from the candidate:
- Basic understanding of European Medical Device Regulations required.
- European Medical device industry experience especially with regulatory, labeling, quality or engineering.
- Experience in technical and or scientific writing
- Familiarity with clinical and non-clinical data literature searches (eg PubMed)
- Ability to review and work according to checklist of requirements.
- Technically versed in computer software such as MS Word, Excel, Powerpoint.
- Strong Analytical Skills
- English and German spoken and written