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 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:

• 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
• Lunch voucher with Swile card
• Reimbursement of public transportation
• Relocation support for international mobilities
• Enrollment in Doctolib’s long-term employee value sharing plan called DoctoGrowth

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!

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