Senior RA/QA Leader for SaMD | Paris (Hybrid)

Dental Monitoring Czech; Paris; Hybride; EUR 95 000 - 135 000; Plein temps

Résumé du poste

DentalMonitoring is seeking a Senior RA/QA Manager to elevate regulatory affairs and quality assurance for SaMD. Based in Paris with a hybrid work model, you will own the RA/QA strategy, partner with leadership and lead a 4–5 person team.

You will drive ISO 13485, MDR, MDSAP compliance, work on regulatory submissions across CE, US and beyond, and prepare the organization for potential PRRC designation, shaping the function and your career.

Qualifications

• 8+ years of RA/QA experience for medical devices.
• Experience with SaMD software is preferred.
• Proven senior/managerial leadership experience.
• Eligibility to act as PRRC under MDR Art. 15.
• Fluent professional English (French is a plus).

Responsabilités

• Define and drive the long-term RA/QA strategy for our SaMD portfolio.
• Partner with top management; report on QMS performance and regulatory options.
• Directly lead, structure and grow a team of 4–5 RA/QA specialists.
• Own our Quality Management System (ISO 13485, MDR, MDSAP) and related processes.
• Work closely with ISO27001 & HDS certifications team.
• Drive regulatory strategy and submissions across CE, US, Australia and beyond.
• Be the face of DentalMonitoring with regulatory authorities and bodies.
• Anticipate regulatory changes (MDR, FDA, AI Act) and turn them into opportunities.
• Act as deputy/back-up PRRC with the goal of becoming PRRC.

Connaissances

RA/QA Management

Regulatory strategy

Executive leadership

ISO 13485

MDR knowledge

FDA knowledge

Formation

Engineering degree or MSc in Regulatory Affairs

Pharmacy degree

Description du poste

DentalMonitoring is seeking a Senior RA/QA Manager to elevate regulatory affairs and quality assurance for SaMD. Based in Paris with a hybrid work model, you will own the RA/QA strategy, partner with leadership and lead a 4–5 person team.

You will drive ISO 13485, MDR, MDSAP compliance, work on regulatory submissions across CE, US and beyond, and prepare the organization for potential PRRC designation, shaping the function and your career.