Strategic RA/QA Leader for SaMD in Paris

Dental Monitoring; Paris; Hybride; EUR 120 000 - 165 000; Plein temps

Avantages offerts par ce poste

Hybrid working

Office in Paris

Résumé du poste

DentalMonitoring in Paris is seeking a Senior RA/QA Manager to elevate regulatory and quality leadership for our SaMD portfolio. You will own the RA/QA strategy, sit with the leadership team, and guide a small team of experts.

This senior role offers a clear development path to PRRC, exposure to MDR, FDA, and AI Act, and the opportunity to shape our regulatory roadmap across CE countries, the US, and beyond.

Qualifications

• 8+ years of RA/QA for medical devices (preferably software/SaMD)
• Experience in senior or managerial roles
• Eligibility to act as PRRC under MDR Art. 15
• Fluent in English; French is a plus

Responsabilités

• Define, own and drive the long-term RA/QA strategy for SaMD
• Lead, structure and grow a team of 4–5 RA/QA specialists
• Own ISO 13485, MDR, MDSAP; manage audits, CAPA, post-market surveillance
• Drive regulatory submissions across CE, US, Australia and beyond

Connaissances

Regulatory leadership

Team leadership

Regulatory affairs

English proficiency

Formation

Engineering, Pharmacy or MSc in Regulatory Affairs

Description du poste

DentalMonitoring in Paris is seeking a Senior RA/QA Manager to elevate regulatory and quality leadership for our SaMD portfolio. You will own the RA/QA strategy, sit with the leadership team, and guide a small team of experts.

This senior role offers a clear development path to PRRC, exposure to MDR, FDA, and AI Act, and the opportunity to shape our regulatory roadmap across CE countries, the US, and beyond.