Regulatory Reviewer for Changes & Technical File

Vertragsart:
Vor Ort
Start:
keine Angabe
Dauer:
Long Term
Von:
Edelway
Ort:
Bern
Eingestellt:
17.08.2013
Land:
flag_no Schweiz
Projekt-ID:
585192

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Regulatory Reviewer for Changes & Technical File

Edelway AG is a Professional Services Consultancy based in Switzerland. One of our best clients, a global pharmaceutical company, based in the Bern/Basel area, is currently looking for a Regulatory Reviewer for Changes & Technical Files to join them on a long term basis (contract or permanent).
Language: English, German is a plus
Start Date: ASAP
Rate: Excellent

THE ROLE:
Review changes conducted for marketed medical devices in order to:
*Assess and document the completeness of the change assessment focusing on the regulatory aspects
*Identify and document deficiencies

Contribute to completion of Technical Files by:
*Reviewing Technical File content for completeness
*Interpreting test data (mechanical, shelf life, sterility, reprocessing, etc ) for allocation to the corresponding articles.
*Supporting non-clinical and clinical literature searches and interpretation.

YOUR PROFILE:
*Basic understanding of European Medical Device Regulations is required
*European Medical device industry experience especially with regulatory, labelling, quality or engineering.
*Experience as a technical and/or scientific writer
*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