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 Support gap and impact analyses between ISO 13485 and MDR 2017/745 requirements. Implement and maintain Doctolib's Quality Management System, including procedures, work instructions, templates, and regulatory documentation Configure and maintain our electronic Quality Management System (e-QMS), ensuring efficient document control, version management, and traceability Prepare and coordinate internal and external audits (certification bodies, notified bodies). Drive QMS adoption across cross-functional teams (Product, Tech, IT, HR, Procurement) through training, enablement, and stakeholder engagement. Lead the constitution of regulatory technical documentation to support CE marking and regulatory submissions. Process Risk Management Define and maintain comprehensive process maps, process descriptions, and associated risk analyses. Design and implement quality dashboards to monitor KPIs, process performance, and compliance metrics. Lead continuous improvement initiatives based on data-driven insights and audit findings. Training Enablement Design and deliver Quality and Regulatory training programs tailored to different functions and roles. Foster a strong quality culture and regulatory awareness across the organization through workshops, communications, and hands-on support. Serve as the go-to expert for quality and regulatory questions, providing practical guidance to teams. Regulatory Intelligence Conduct regulatory watch activities, with particular focus on AI/ML-specific standards, regulations, and guidance documents. Assess the impact of regulatory changes on Doctolib's products and processes, proposing mitigation strategies. Cross-Functional Collaboration Partner closely with Tech, Product, Data Science, Medical Affairs, Legal, and Operations to embed quality and regulatory requirements into product development and business processes. Act as a bridge between QARA and operational teams, translating regulatory requirements into actionable, practical guidance. Support product teams throughout the software development lifecycle to ensure compliance 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 non-regulatory audiences. What makes you successful in this role: Drive and Autonomy : You are comfortable w ... (truncated, view full listing at source)