Senior RA/QA Manager - Paris

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

Senior RA/QA Manager - Paris

Regulatory - Paris, France (Hybrid)

Employment Type: Permanent Full-Time

DentalMonitoring is a MedTech scale-up in a fast-growing medical field. We are looking for new talent to join our team!

About DentalMonitoring

• DentalMonitoring is a leader in orthodontics, offering the industry’s first AI-powered remote monitoring solution certified as a medical device
• Our mission is to set a new standard of care by combining advanced technology with strong commitments to quality, efficiency, patient and doctor experience
• Our platform helps practices enhance clinical control, optimize workflows, and deliver more personalized patient care
• Our proprietary AI analyzes scans and provides actionable insights, enabling proactive and timely clinical intervention, supported by 13,000+ clinical data results
• We provide a full ecosystem of support, including onboarding, training, and marketing tools, continuously redefining what’s possible in orthodontic care

If you are a Senior RA/QA Manager with a minimum of 8 years experience, the following may interest you!

The Senior RA/QA Manager Role

We are looking for a Senior RA-QA Manager to take the regulatory affairs and quality assurance function to the next level. This is a senior, strategic and highly visible position: you will own the RA/QA strategy for our SaMD portfolio, sit at the table with our leadership team, and lead a team of regulatory and quality experts. You will also work hand-in-hand with our Manager to progressively take over key missions and ensure a back-up and potential succession (mid-term), making this a genuine opportunity to shape both the function and your own career.

What you will Do

• Define, own and drive the long‑term RA/QA strategy and roadmap for our SaMD portfolio, aligned with our corporate, commercial and R&D ambitions.
• Partner with top management: report on QMS performance, regulatory risk and strategic options directly to the Chief Market Access Officer and the Executive Committee, and help steer company‑level decisions.
• Directly lead, structure and grow a team of 4–5 RA/QA specialists — setting objectives, developing talent and building a high‑performing, collaborative culture.
• Own our Quality Management System (ISO 13485, MDR, MDSAP) and the key processes behind it: audits, CAPA, post‑market surveillance, change control, supplier quality, training and product release.
• Work closely with the team in charge of ISO27001 & HDS certifications
• Drive regulatory strategy and submissions across CE countries, the US, Australia and beyond, and maintain registrations throughout the product life cycle.
• Be the face of Dental Monitoring with regulatory authorities, notified bodies and industry associations.
• Anticipate regulatory change — MDR, FDA, MDSAP, the AI Act and more — and turn it into a competitive advantage for the business.
• Act as deputy / back‑up Person Responsible for Regulatory Compliance (PRRC, MDR Art. 15), with the goal of becoming the titular PRRC at medium term.

What we are looking for

• A degree in engineering, pharmacy or an MSc in Regulatory Affairs or a medical/scientific field.
• Significant experience (typically 8+ years) in RA/QA for medical devices — ideally software / SaMD — including a proven track record in a senior or managerial role.
• High interest in new technology which includes working with AI experts and adopt new methodologies in the RA/QA daily missions
• Real leadership experience: you have managed and developed specialist teams and are comfortable influencing at executive level.
• Eligibility to act as PRRC under MDR Article 15.
• Solid command of ISO 13485, ISO 14971, MDSAP, MDR 2017/745 and IEC 62304; familiarity with FDA and international regulations is a plus.
• A strategic, business‑minded approach — you turn regulatory and quality constraints into options and opportunities.
• Rigor, analytical skills, and fluent professional English (French is a plus).

Why join us

• A role with real scope and impact, at the crossroads of regulatory strategy, quality leadership and executive decision‑making.
• A clear development path, including a route to PRRC and to broader regulatory & quality leadership.
• An international, fast‑growing MedTech scale‑up where AI meets healthcare — and where your work directly helps clinicians and patients.
• A collaborative, diverse and ambitious team, flexible/hybrid working, and offices in the heart of Paris.

Our Work Environment

• We are collaborators! It is a core value, and our team of researchers, doctors, developers, salespeople, and all of our stakeholders work together to put our customers first!
• DentalMonitoring is a diverse, multicultural company: you can find more than 35 nationalities throughout our teams

DentalMonitoring is an equal opportunity employer and offers an intercultural and inclusive workplace. The diversity of our teams is one of our strengths. We work every day with more than 35 nationalities in different countries all over the world. We welcome and encourage applications from people with disabilities. We are committed to providing appropriate accommodation.