Technical Project Manager, Clinical & Regulatory Affairs

Withings

. Run the FDA and CE submission dashboard, tracking deadlines, deliverables and owners and chasing every item to completion.

Posted 10/28/2026full-timeIssy-les-Moulineaux • FranceMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in project management and regulatory compliance within the medical devices or pharma industry, with strong capabilities in data analysis and stakeholder communication. Proficient in Python scripting and AI tools to enhance operational efficiency and ensure quality in submissions.

Highest-signal resume keywords

Project ManagementRegulatory CompliancePython ScriptingStakeholder ManagementAI Tools Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Project ManagementData AnalysisPythonQuality AssuranceRegulatory MonitoringSubmission PreparationMarket AuthorizationValidation ReproductionEstablishment RegistrationDevice Listing

Soft Skills

Clear Written CommunicationAttention to DetailFast LearnerCollaboration

Tools & Technologies

AI ToolsSubmission DashboardESTAR

Industry Keywords

FDACEMedical DevicesPharmaISO 13485ISO 14971Regulated Industry

Tech Stack

Tools & technologies

Python

About the role

Key responsibilities & impact

Run the FDA and CE submission dashboard, tracking deadlines, deliverables and owners and 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, including establishment registration, user fees and device listing.
Run regulatory and competitive monitoring and publish a short weekly brief.
Coordinate data and evidence checks, including reproducing validation results in Python and reviewing medical claims.
Manage compliance requests from distributors and authorities and maintain the market authorization matrix.
Build reusable AI tools and workflows for the team.
Work directly with the Chief Clinical & Regulatory Affairs Officer, owning operational execution while the officer owns strategy and final decisions.
Collaborate with the QARA team, the wider Medical Department, and product, legal and commercial teams.

Requirements

What you’ll need

3–6 years in project or program management, consulting, operations, or a technical role leading cross-functional work.
Strong project management skills; ability to run several workstreams with hard deadlines and close every loop.
Strong stakeholder management and clear written communication.
Comfortable with data and scripting (Python or similar).
Regular, hands-on use of AI tools, with the judgment to check their output.
Fast learner with high attention to detail.
Degree in engineering, computer science or another quantitative field, or equivalent experience.
Fluent professional English, written and spoken.
Experience in medical devices, pharma or another regulated industry, or familiarity with FDA, CE/MDR or ISO 13485 and 14971 is nice to have.
French is a plus.

Benefits

Comp & perks

Joining one of the pioneers and global leaders in connected health, recognized with multiple awards at the Consumer Electronics Show.
Contributing to innovative and ambitious projects focused on shaping the future of healthcare.
Working in an international environment alongside teams based in Issy-les-Moulineaux, Boston, Hong Kong, and Shenzhen.
Playing a direct role in improving our products and services, including testing them before launch.
Expanding your medical knowledge through the Withings Med Academy and regular presentations from healthcare professionals.
Stock options.
Choice of smartphone and computer.
On-site company restaurant.
Cultural and sports perks.