Lead identification, development, architecture, and optimizations of the Quality Management System, at both Global and Site levels. Work collaboratively and support process owners…
The selected candidate is responsible for ensuring that each individual batch has been manufactured in compliance with laws in force in the country of destination, in accordance wi…
Provide Regulatory strategies for projects as RA representative in cross-functional teams Responsible for regulatory Assessment on product changes Coordinate the preparation of r…
Directs the preparation and coordination of comprehensive regulatory submissions for Medical Devices, ensuring compliance with local and international regulations and achieving com…
Support team members in creating CE Mark submissions and change notifications to our Notified Body (NB), including responding to regulatory inquiries Aid in the completion and upk…
Vigilance & complaint processes management ; Support in post-market surveillance activities ; Medical device data management, creation and maintenance of associated documentation…
Generate and lead site metrics reviews such as KPI reviews and Quality Data Reviews. Manage Local and Global Quality Reports and other metrics reviews as applicable. Coordinate t…
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