Clinical & Regulatory PM: FDA/CE Submissions
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Withings in Issy-les-Moulineaux is seeking a technical project manager to organize regulatory and clinical work. You will plan, track, and drive FDA and CE submissions in collaboration with the Chief Clinical & Regulatory Affairs Officer, owning the execution plan and follow-through.
You will coordinate across Regulatory, QMS, Clinical Operations, Medical Data Sciences, and product/legal teams, ensuring timely deliverables and effective use of AI tools with human verification.
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Technical Project Manager, Clinical
Il y a 4 jours
Issy-les-Moulineaux, Île-de-France Withings Temps pleinDescriptionAbout Withings:Withings designs connected health devices (scales, blood pressure monitors, ECG watches, an under-mattress sleep sensor) and AI-based medical software (SaMD) used every day by millions of people. Our Medical Department runs several FDA 510(k) submissions, CE certification under the EU MDR, and clinical studies in France and the US...
