Description
I am currently seeking a Medical Devices - QA/RA specialist for a 6-10 weeks FDA audit preparation project in Switzerland.Start: ASAP
Duration: 6-10+ weeks
FTE: 1.0
Location: Basel area
Industry: Medical Devices
Rate: Negotiable
Task:
Prepare the facility including the documentation (French/English) for a FDA audit.
- Document review (validation reports, risk files, CAPA etc)
- GAP analysis
- Perform necessary changes / update documentation
- Reach compliance level with FDA requirements
- Prepare documents for translation into English
Requirements:
- Strong medical devices experience (6+ years)
- ISO 13485
- Very good QA/RA understanding
- Sound knowledge regarding FDA regulations/requirements
- French fluently + English business fluent
- Good communication skills
- Project management experience
- Ideally Auditor certification and previous FDA audit preparation experience
If this role is of interest for you, please send your CV in Word including your hourly rate expectation for immediate consideration.
For more information you can reach me on .