Beschreibung
Regulatory Reviewer for Labeling and ChangesI am seeking a Regulatory Reviewer for Labeling and Changes for a 5 month project in Switzerland.
This is your chance to become a part in one of the biggest Medical Devices projects in Switzerland within a global top 10 Medical Devices company.
Requirenments:
- 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.
Due to the urgency of this position, my client isn't able to provide consultants from outside the EU25 with work permits for Switzerland.
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
Details:
Start date: ASAP
Project length: 5 Months
Salary: negotiable
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. You can reach me on or m.muller'at'realstaffing.com
Keywords: Reviewer, Labeling and Changes, Medical Device, Medical Device Regulation, regulatory, labelling, quality, engineering, GDP, instructions, guides, German AND English, Switzerland, Freelance
Campaign Ref: CH
To find out more about Real please visit www.realstaffing.com