Senior RA/QA Strategy Lead – SaMD & MDR Expert

DentalMonitoring; Paris; Hybride; EUR 110 000 - 150 000; Plein temps

Avantages offerts par ce poste

Hybrid working

Office in Paris

Diversity & inclusion

Résumé du poste

DentalMonitoring, a Paris-based MedTech scale-up, seeks a Senior RA/QA Manager to elevate regulatory affairs and quality assurance for our SaMD portfolio. You will own the RA/QA strategy, work with leadership, and lead a team of regulatory and quality experts to ensure strong compliance and strategic execution.

In this role you will drive ISO 13485, MDR, MDSAP programs, manage audits, CAPA, and post-market surveillance, and coordinate with authorities across CE, US, and beyond.

Qualifications

• 8+ years in RA/QA for medical devices, preferably SaMD.
• Experience leading a 4–5 person RA/QA team.
• Eligibility to act as PRRC under MDR Article 15.
• Fluent professional English; French a plus.

Responsabilités

• Define and drive long-term RA/QA strategy for SaMD portfolio.
• Report on QMS performance and regulatory risk to executives.
• Lead and develop a 4–5 RA/QA team.
• Own ISO 13485, MDR, MDSAP, CAPA, post-market surveillance.
• Drive regulatory strategy across CE, US, AU and beyond.
• Be the face of DentalMonitoring with authorities.

Connaissances

Regulatory leadership

Regulatory strategy

Quality management

Team leadership

English fluent

Formation

Engineering degree

Pharmacy degree

MSc Regulatory Affairs

Outils

ISO 13485

MDR

MDSAP

IEC 62304

Description du poste

DentalMonitoring, a Paris-based MedTech scale-up, seeks a Senior RA/QA Manager to elevate regulatory affairs and quality assurance for our SaMD portfolio. You will own the RA/QA strategy, work with leadership, and lead a team of regulatory and quality experts to ensure strong compliance and strategic execution.

In this role you will drive ISO 13485, MDR, MDSAP programs, manage audits, CAPA, and post-market surveillance, and coordinate with authorities across CE, US, and beyond.