Regulatory Reviewer (Labelling and Medical Devices)

Vertragsart:
Vor Ort
Start:
09/09/2013
Dauer:
4-6 months
Von:
Berry Technical
Ort:
Solothurn
Eingestellt:
14.09.2013
Land:
flag_no Schweiz
Projekt-ID:
598971

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Regulatory Reviewer (Labelling and Medical Devices)
6 month contract
Solothurn, Switzerland
CHF Negotiable

Our client, an expanding global giant in their industry, is currently expanding their quality and validation department and seeking experienced medical device regulatory reviewers to join their team in Solothurn.

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 labelling 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

What we require from the candidate:

- 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.
- Strong Analytical Skills
- English and German spoken and written
- 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

Please email.