Regulatory Strategy Lead for Robotic Surgery

Surgitec Robotics; Amiens; On-site; EUR 60,000 - 90,000; Full time

Job summary

Surgitec Robotics is seeking a Regulatory Affairs Specialist to translate EU MDR 2017/745 and FDA 510(k) requirements into actionable steps. You will collaborate with R&D, QA, and leadership to build a robust regulatory strategy and documentation for a robotic surgery platform.

The role covers design reviews, device classifications, and regulatory registrations, with emphasis on accelerating compliant pathways and CE/FDA submissions in a startup environment.

Qualifications

• 5–7 years in Regulatory Affairs for complex medical devices (hardware, software, AI).
• Experience with CE submissions (MDR) and FDA 510(k) / PMA is mandatory.
• Knowledge of standards such as MDR Annexes, IEC 62304, IEC 60601, ISO 14971.

Responsibilities

• Define and drive regulatory strategy for EU and US markets.
• Prepare and coordinate Technical File / Design Dossier, and regulatory submissions.
• Interface with R&D, QA, and leadership to embed regulatory in product development.
• Lead PMCF plans, PMS, and vigilance activities per MDR requirements.
• Maintain registrations (EUDAMED, FDA GUDID) and CE certifications.

Skills

Regulatory strategy

MDR/EU compliance

FDA regulatory pathways

Regulatory submissions

Cross-functional collaboration

Education

Master’s degree in Quality/Biomedical Engineering

Tools

EUDAMED knowledge

Technical File/Design Dossier preparation

Job description

Surgitec Robotics is seeking a Regulatory Affairs Specialist to translate EU MDR 2017/745 and FDA 510(k) requirements into actionable steps. You will collaborate with R&D, QA, and leadership to build a robust regulatory strategy and documentation for a robotic surgery platform.

The role covers design reviews, device classifications, and regulatory registrations, with emphasis on accelerating compliant pathways and CE/FDA submissions in a startup environment.