Clinical & Regulatory PM: FDA/CE Submissions

Withings; Issy-les-Moulineaux; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Stock options

Choice of smartphone

Choice of computer

On-site company restaurant

Cultural and sports perks

Job summary

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.

Qualifications

• 3-6 years in project or program management, consulting, operations, or a technical leadership role.
• Ability to run multiple workstreams with hard deadlines and close loops.
• Excellent written communication and stakeholder management.
• Comfort with data and scripting (Python or similar).
• Experience using AI tools with a human-in-the-loop mindset.

Responsibilities

• Plan, track and drive FDA and CE submissions with timelines and owners.
• Convert FDA letters into work plans and lead check-ins with contributors.
• Assemble and quality-check submission packages (eSTAR) and draft sections.
• Handle FDA establishment registration, user fees, and device listing.
• Monitor regulatory landscape and publish weekly briefs.
• Coordinate data checks, reproduce validation results in Python, review medical claims.
• Manage compliance requests from distributors and authorities, maintain matrices.
• Build reusable AI tools and workflows for the team.

Skills

Project management

Stakeholder management

Written communication

Python scripting

AI tools usage

Attention to detail

Education

Engineering or Computer Science degree

Tools

Python

Job description

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.