Senior Regulatory & QA Lead - SaMD, Paris (Hybrid)

Dental Monitoring Czech; Paris; Hybrid; EUR 110,000 - 150,000; Full time

Job summary

DentalMonitoring in Paris is seeking a Senior RA/QA Manager to elevate regulatory affairs and quality assurance for our SaMD portfolio. You will shape strategy, lead a 4–5 person team, and partner with senior leadership to align regulatory plans with business goals.

You will own ISO 13485, MDR and related processes, coordinate global submissions, and act as the main liaison with authorities. This is a hybrid Paris-based role offering significant influence and career growth.

Qualifications

• Minimum 8 years of RA/QA experience in medical devices, preferably SaMD.
• Experience leading a team of 4–5 specialists and interacting with executives.
• Strong knowledge of ISO 13485, MDR, MDSAP and IEC 62304.
• Eligibility to act as PRRC under MDR Article 15.
• Fluent professional English; French is a plus.

Responsibilities

• Define and own the long-term RA/QA strategy for our SaMD portfolio.
• Report on QMS performance and regulatory risk to leadership.
• Directly lead and grow a 4–5 RA/QA team.
• Maintain registrations across CE countries, the US, Australia and beyond.
• Coordinate regulatory submissions and act as primary liaison with authorities.
• Drive MDR, FDA, MDSAP compliance and anticipate regulatory changes.

Skills

RA/QA leadership

Regulatory affairs

Medical devices

ISO 13485

MDR 2017/745

FDA regulations

English proficiency

PRRC eligibility

Education

Engineering degree

Pharmacy degree

MSc Regulatory Affairs

Job description

DentalMonitoring in Paris is seeking a Senior RA/QA Manager to elevate regulatory affairs and quality assurance for our SaMD portfolio. You will shape strategy, lead a 4–5 person team, and partner with senior leadership to align regulatory plans with business goals.

You will own ISO 13485, MDR and related processes, coordinate global submissions, and act as the main liaison with authorities. This is a hybrid Paris-based role offering significant influence and career growth.