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

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 German or Italian, a real plus as we continue to expand across Europe. What we offer • Free health insurance for you and your children • Parent Care Program: receive one additional month of leave on top of the legal parental leave • Free mental health and coaching services through our partner Moka.care • For caregivers and workers with disabilities, a package including an adaptation of the remote policy, extra days off for medical reasons, and psychological support • Work from abroad for up to 10 days per year thanks to our flexibility days policy • Work Council subsidy to refund part of sport club membership or creative class • Up to 14 days of RTT • A subsidy from the work council to refund part of the membership to a sport club or a creative class • Lunch voucher with Swile card • Reimbursement of public transportation • Relocation support for international mobilities The interview process • Recruiter Interview (30’ remote) • Hiring Manager Interview (1h remote) • Business Case (1h onsite) • Final Interview (45’ remote) • At least one reference check Job details • Permanent position • Full Time • Workplace: Levallois-Perret (92, France) • Start date: asap • Compensation : fix + bonus on objectives (according to your profile) • Partial remote allowed (2 days per week) At Doctolib, we are committed to improving access to healthcare for everyone. This translates into our recruitment process. We evaluate candidates based solely on qualifications and motivation, without any form of discrimination. The more diverse ideas are heard, the more our product will truly improve healthcare for all. You are welcome to apply to Doctolib, regardless of your gender, religion, age, sexual orientation, ethnicity, disability. To ensure equal opportunities, we invite you to exclude personal information (e.g. pictures, age) from your applications. If you require any accommodation, please let us know for support during the hiring process. Join us in building the healthcare we all dream of! All information provided is processed by Doctolib for application management. For data processing details, click here: Germany l France l Italy l Netherlands. Please contact hr.dataprivacy(at)doctolib.com to exercise your rights.