Description
Senior Project Manager with experience in QA-RA, SwitzerlandFor our client, a recognized company pioneer in the medical device industry based in Geneva, Switzerland, we are currently looking for a Senior Project Manager with QA-RA experience. This one year project will begin ASAP.
Within the role, it is required full time work on site to support a remediation project. You would be responsible 50% on project management reporting to a steering committee and 50% with one of the work streams supporting design control, technical file reviews, DMR, DHF, 13485 & 60601, EN62304, EN62366 compliance for class II a / b Medical Devices (electrical driven handhold equipment).
Your tasks would also be the following:
- Make sure that the Technical Files has proper and adequate structure and it links to all needed evidences
- Support other functions (like R&D, Validation, Test engineering, Manufacturing) to produce or remediate missing/incomplete evidences.
- Oversee the full traceability (from Design to Test cases to Design transfer).
- Review documents for compliance with relevant Standards and Regulations and suitability of the technical contents and of the technical file for CE marking.
- Advice on proper device classification and applicable standards and provide guidance.
Your profile:
- Excellent Project Management skills in medical device environment
- Design control experience
- Tech file remediation
- DMR, DHF (STED)
- Deep knowledge of Standards for PEMS as ISO 13485, IEC 60601, EN 62304, EN 62366
- Knowledge in reporting and performing audits
- At least 8 years of experience in Quality Assurance-Regulatory Affairs (QARA) for medical devices.
- Languages: Fluency in English. French as nice to have.
KEYWORDS: Project Manager - QA - RA - Electrical Equipment - Medical Device - IEC 60601
Should this role be of interest for you, please contact Nicolas Vicari at Real Staffing on or