Senior RA/QA Manager

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.