Senior RA/QA Manager (SaMD)

Location: Paris, France — hybrid

Company

hirify.global is a MedTech scale-up providing an AI-powered remote monitoring solution for orthodontic practices, certified as a medical device.

What you will do

• Define and drive the long-term RA/QA strategy and roadmap for the Software as a Medical Device (SaMD) portfolio.
• Report on QMS performance, regulatory risks, and strategic options to the Chief Market Access Officer and Executive Committee.
• Lead, structure, and develop a team of 4–5 regulatory and quality specialists.
• Own the Quality Management System and processes covering audits, CAPA, post-market surveillance, change control, supplier quality, training, and product release.
• Drive regulatory strategies and submissions across CE countries, the US, Australia, and other markets, maintaining registrations throughout the product life cycle.
• Represent hirify.global with regulatory authorities, notified bodies, and industry associations while acting as deputy PRRC and progressing toward the titular PRRC role.

Requirements

• Degree in engineering, pharmacy, regulatory affairs, or a medical/scientific field.
• At least 8 years of RA/QA experience in medical devices, ideally software or SaMD, including senior or managerial experience.
• Eligibility to act as PRRC under MDR Article 15.
• Strong knowledge of ISO 13485, ISO 14971, MDSAP, MDR 2017/745, and IEC 62304; familiarity with FDA and international regulations is advantageous.
• Experience managing and developing specialist teams and influencing executive-level decisions.
• Fluent professional English required; French is a plus.

Nice to have

• Experience with FDA and international medical-device regulations.
• French language skills.
• Experience working with AI experts and adopting new methodologies in RA/QA.

Culture & Benefits

• Strategic role connecting regulatory strategy, quality leadership, and executive decision-making.
• Development path toward PRRC and broader regulatory and quality leadership responsibilities.
• Flexible hybrid working arrangement with offices in central Paris.
• International, multicultural, collaborative, and inclusive environment with more than 35 nationalities.
• Work alongside researchers, doctors, developers, salespeople, and other stakeholders in an AI-focused healthcare business.