Description
I am seeking a Regulatory Reviewer for Labeling and Changes for a 6 month project in Switzerland.Requirements:
- Basic understanding of European Medical Device Regulations (93/42/EEC) required.
- European Medical device industry experience especially with regulatory, labeling, quality or engineering.
- Knowledge of Good Documentation Practice (GDP)
- Ability to review and work according to checklist of requirements.
- Technically versed in computer software such as MS Word, Excel, Powerpoint.
- English and German spoken and written
The responsibilities of this position include:
Acting as a reviewer of label and labeling material (package label, Instructions for use, Surgical Technique Guides) in order to:
- assure consistency of labeling content
- identify and document inconsistencies
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
For more information about this role or jobs within related specialist areas please send me your CV with your hourly rate expectation for immediate consideration.