Senior RA/QA Leader – SaMD Regulatory & Quality Strategy

DentalMonitoring; Paris; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

DentalMonitoring, a Paris-based MedTech scale-up, seeks a Senior RA/QA Manager to own the regulatory affairs and quality assurance strategy for its SaMD portfolio. You will lead a 4–5 person team, partner with senior leadership, and shape the function with potential succession planning.

This is a high-visibility role at the crossroads of regulatory strategy and executive decision-making. You will drive audits, CAPA, post-market surveillance, and certifications (ISO 13485, MDR, MDSAP, IEC 62304),

Qualifications

• 8+ years in RA/QA for medical devices (SaMD)
• Experience leading 4–5 RA/QA specialists
• Eligibility to act as PRRC under MDR Art.15
• Fluent professional English; French is a plus
• Strong knowledge of ISO 13485, MDR, MDSAP, IEC 62304

Responsibilities

• Define and own long-term RA/QA strategy and roadmap for SaMD
• Lead and grow a 4–5 person RA/QA team
• Own ISO 13485, MDR, MDSAP processes (audits, CAPA, post-market)
• Interface with regulatory authorities and notified bodies
• Drive regulatory submissions across CE, US, Australia

Skills

Regulatory leadership

QA management

Strategic planning

ISO 13485

MDR expertise

PRRC experience

Regulatory submissions

Process improvement

Team development

Education

Engineering degree

Pharmacy degree

MSc Regulatory Affairs

Job description

DentalMonitoring, a Paris-based MedTech scale-up, seeks a Senior RA/QA Manager to own the regulatory affairs and quality assurance strategy for its SaMD portfolio. You will lead a 4–5 person team, partner with senior leadership, and shape the function with potential succession planning.

This is a high-visibility role at the crossroads of regulatory strategy and executive decision-making. You will drive audits, CAPA, post-market surveillance, and certifications (ISO 13485, MDR, MDSAP, IEC 62304),