QARA (Quality Assurance and Regulatory Affairs) Program Manager (x/f/m)

What you’ll do At Doctolib, we believe that technology and AI can help reinvent the work of healthcare professionals and improve people's health. To deliver increasing medical value to our users, we're embarking on our medical device certification journey - this is where you come in! As a QARA Program Manager at Doctolib, you will play a critical role in establishing and continuously improving our Quality Management System (QMS) to ensure compliance with medical device regulations. You'll work at the intersection of quality, regulatory affairs, and product development, enabling our teams to deliver safe, compliant, and innovative Software as a Medical Device (SaMD) solutions that transform healthcare. Your responsibilities include but are not limited to: Quality and Regulatory compliance : Design, implement and continuously improve Doctolib's Quality Management System, ensuring ISO 13485 and MDR 2017/745 requirements are fully integrated into our operations, from documentation and audit readiness to CE marking and regulatory submissions. Own our e-QMS to guarantee robust document control, version management, and traceability across the organization. Process Risk management : Own our quality dashboards and KPIs, leverage process performance and compliance metrics to surface risks early, drive continuous improvement initiatives, and give leadership the visibility they need to make informed decisions. Training Quality culture: Design and deliver targeted training programs across functions, making regulatory compliance intuitive and actionable for everyone, from engineers to business teams, and serve as the trusted go-to expert for quality and regulatory questions. Regulatory intelligence: Lead regulatory watch activities with a strong focus on AI/ML-specific standards and regulations, assess their impact on Doctolib's products and processes, and translate complexity into clear, actionable mitigation strategies. Cross-functional collaboration : Act as a bridge between QARA, Tech, Product, Data Science, Legal, and Operations, ensuring compliance is a built-in feature of everything we ship, from concept to post-market surveillance. Who you are Before you read on — if you don't have the exact profile described below, but you feel this job description matches your skill set, we still encourage you to apply. You could be our next team mate if: You are fluent in English and French. You bring at least 4-6 years of experience with Software as a Medical Device (SaMD) regulatory compliance , with a proven track record of participating in or leading CE marking processes for Class IIa devices and above. You have deep knowledge of medical device regulations and standards , particularly ISO 13485, MDR 2017/745, and the software development lifecycle standards IEC 62304 and IEC 82304. You combine analytical thinking, structured problem-solving , and excellent project management skills to drive compliance initiatives across multiple stakeholders. You communicate with impact : You can translate regulatory complexity into clear, actionable guidance for diverse audiences. What makes you successful in this role: Drive and Autonomy : You are comfortable working independently, taking ownership of your projects with an entrepreneurial mindset. Relationship building : You are a team player and proactively create connections with stakeholders across the organization. Pragmatism : You know how to translate regulations into pragmatic, actionable guidance in a fast-moving, regulated environment. Now, it would be fantastic if you: Have a medical or scientific background (pharmacist, engineer, Master's in Quality/Regulatory Affairs for medical devices, or equivalent). Have hands-on experience implementing or maintaining an electronic Quality Management System (e-QMS). Are familiar with AI/ML-based medical devices and their specific regulatory considerations, including the EU AI Act and FDA guidance on AI/ML software. Speak G ... (truncated, view full listing at source)