Beschreibung
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 Labelling & Changes to Medical Devices to join them on a long term basis (contract or permanent).
Language: English, German is a plus
Start Date: ASAP
Rate: Excellent
The Role:
The responsibilities of this position include:
*Acting as a reviewer of label and labelling material (package label, Instructions for Use, Surgical Technique Guides) in order to:
o assure consistency of labelling content
o identify and document inconsistencies
*Acting as a reviewer of changes conducted for marketed medical devices in order to:
o assess and document completeness of change assessment with focus on Regulatory aspects
o identify and document deficiencies
Your Profile:
*Basic understanding of European Medical Device Regulations (93/42/EEC) required.
*European Medical device industry experience especially with regulatory, labelling, 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.
If this sounds like your next challenge send us your CV and we will call you to discuss the role in more details.