- Location
- Issy-les-Moulineaux, Île-de-France, France · published
- Type
- Full-time
- Department
- Legal
- Seniority
- Manager
- Clearance
- Not required
- Source
- Workable
Description
About 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 in parallel. Since 2023, it has obtained four FDA 510(k) clearances and several CE certifications under the MDR. Its tools support early detection of cardiometabolic diseases. The goal is to speed up both their development and the regulatory submissions that certify them in Europe and the US, with decentralized clinical studies as the default.
About the role:
We're looking for a technical project manager to keep our clinical and regulatory work organized and moving. Working directly with the Chief Clinical & Regulatory Affairs Officer, you'll plan, track and drive FDA and CE submissions, regulatory monitoring, data verification and compliance requests across the department. The Chief Clinical & Regulatory Affairs Officer owns strategy and final decisions; you own the plan and the follow-through.
You are the Chief Clinical & Regulatory Affairs Officer's right hand: they own the decisions, you own the execution. The Chief Clinical & Regulatory Affairs Officer keeps regulatory strategy, all exchanges with the FDA and notified bodies, partnerships, clinical study design, and every final sign-off. You prepare the work behind those decisions, so that strategy is no longer held up by the operational preparation of submissions.
The role suits a young biomedical engineer who wants to learn the regulatory and clinical side of connected medical devices and AI, close to where decisions are made.
About the team:
The Medical Department has about 30 people in four teams: Regulatory & QMS (QARA), Clinical Operations & decentralized trials, Medical Data Sciences & AI, and Medical (public funding and training). You'll sit with the QARA team day to day and work across all four, as well as with product, legal and commercial teams. The department uses Claude and other AI tools every day, with one rule: AI drafts, a human always verifies.
Responsibilities:
- Run the FDA and CE submission dashboard: deadlines, deliverables and owners, chasing every item to completion.
- Turn FDA letters and submissions into work plans, and run check-ins with contributors.
- Assemble and quality-check submission packages (eSTAR), and coordinate first drafts of factual sections for review.
- Handle FDA administration: establishment registration, user fees, device listing.
- Run regulatory and competitive monitoring, and publish a short weekly brief.
- Coordinate data and evidence checks, such as reproducing validation results in Python and reviewing medical claims.
- Manage compliance requests from distributors and authorities, and keep the market authorization matrix up to date.
- Build reusable AI tools and workflows for the team.