Senior Regulatory Affairs & QA Manager (Paris)

About the role

DentalMonitoring seeks a senior professional to lead the regulatory affairs and quality assurance function for its SaMD portfolio. This strategic, high‑visibility position reports directly to senior leadership and offers the chance to shape both the function and your career.

Key responsibilities

• Define and drive long‑term RA/QA strategy and roadmap for the SaMD portfolio, aligned with corporate, commercial and R&D goals.
• Report QMS performance, regulatory risk and strategic options to the Chief Market Access Officer and the Executive Committee, influencing company‑level decisions.
• Lead, structure and grow a team of 4‑5 RA/QA specialists, setting objectives, developing talent and fostering a collaborative culture.
• Own the Quality Management System (ISO 13485, MDR, MDSAP) and manage audits, CAPA, post‑market surveillance, change control, supplier quality, training and product release.
• Coordinate with the ISO 27001 & HDS certification team and ensure compliance.
• Drive regulatory submissions and maintain registrations in CE, US, Australia and other markets throughout the product lifecycle.
• Act as the company’s face with notified bodies, regulatory authorities and industry associations, anticipating changes such as the AI Act.
• Serve as deputy PRRC with the aim to become the primary PRRC in the medium term.

Required profile

• Engineering, pharmacy, MSc in Regulatory Affairs or a related scientific discipline.
• Minimum 8 years of RA/QA experience in medical devices, preferably software‑as‑a‑medical‑device, with a proven senior or managerial track record.
• Demonstrated leadership of specialist teams and ability to influence executive stakeholders.
• Eligibility to act as PRRC under MDR Article 15.
• Fluent professional English; French is a plus.

Required skills

• Deep knowledge of ISO 13485, ISO 14971, MDR 2017/745, IEC 62304 and MDSAP.
• Familiarity with FDA regulations and international regulatory frameworks.
• Experience with ISO 27001 and HDS certification processes.

What we offer

• Strategic role with direct impact on regulatory and quality direction.
• Clear career path toward PRRC and broader leadership responsibilities.
• Fast‑growing international MedTech scale‑up where AI meets healthcare.
• Diverse, collaborative team with flexible/hybrid working and a central Paris office.