Beschreibung
For our customer in Solothurn we are looking for a Regulatory Reviewer for Changes and Technical Files
The responsibilities of this position include the 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 If you are interested in this position please do not hesitate to send us your CV electronically. Many thanks.
