Regulatory-Tech PM for FDA/CE Submissions

SportsTechJobs; Issy-les-Moulineaux; Remoto; EUR 70.000 - 100.000; Tempo pieno

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On-site restaurant

Cultural perks

Sports perks

Descrizione del lavoro

Withings is seeking a Technical Project Manager for Clinical & Regulatory Affairs in Issy-les-Moulineaux, France. You will plan, track and drive FDA and CE submissions, regulatory monitoring and data verification, collaborating with the Chief Clinical & Regulatory Affairs Officer to move complex processes forward.

Ideal candidates have 3–6 years in project management, strong stakeholder skills, and a quantitative technical background.

Competenze

• 3–6 years in project or program management or related roles.
• Fluent professional English, written and spoken; French is a plus.
• Degree in engineering, computer science or another quantitative field, or equivalent experience.

Mansioni

• Manage FDA and CE submissions dashboards, deadlines and owners.
• Turn letters and submissions into work plans and track progress.
• Coordinate submission packages and draft factual sections for review.
• Handle FDA establishment registration and device listings.
• Build reusable AI tools and workflows for regulatory teams.

Conoscenze

Project management

Stakeholder management

Python

AI tools

FDA submissions

CE/MDR

Regulatory affairs

Clinical operations

Data verification

ISO 13485

Formazione

Engineering / CS / quantitative field

Strumenti

Python

AI tools

Descrizione del lavoro

Withings is seeking a Technical Project Manager for Clinical & Regulatory Affairs in Issy-les-Moulineaux, France. You will plan, track and drive FDA and CE submissions, regulatory monitoring and data verification, collaborating with the Chief Clinical & Regulatory Affairs Officer to move complex processes forward.

Ideal candidates have 3–6 years in project management, strong stakeholder skills, and a quantitative technical background.