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

<h2><strong>What you’ll do</strong></h2> <p>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! </p> <p>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.</p> <p>Your responsibilities include but are not limited to:</p> <p><strong>Quality and Regulatory Compliance </strong></p> <ul> <li>Support gap and impact analyses between ISO 13485 and MDR 2017/745 requirements.</li> <li>Implement and maintain Doctolib's Quality Management System, including procedures, work instructions, templates, and regulatory documentation</li> <li>Configure and maintain our electronic Quality Management System (e-QMS), ensuring efficient document control, version management, and traceability</li> <li>Prepare and coordinate internal and external audits (certification bodies, notified bodies).</li> <li>Drive QMS adoption across cross-functional teams (Product, Tech, IT, HR, Procurement) through training, enablement, and stakeholder engagement.</li> <li>Lead the constitution of regulatory technical documentation to support CE marking and regulatory submissions.</li> </ul> <h4><strong>Process & Risk Management</strong></h4> <ul> <li>Define and maintain comprehensive proce