QARA Engineer

<p>Robeauté is redefining the future of neurosurgery with self-propelled microrobots designed to navigate the human brain with unprecedented precision. Our technology makes it possible to reach deep brain regions that were previously inaccessible, without invasive surgery.</p><p>We’ve developed microrobots capable of travelling inside the brain to collect biopsies, deliver cancer drugs, and implant electrodes for neurological treatments.</p><p>Since our founding in 2017, we’ve filed 50+ patents and successfully tested our technology in living animals, with human clinical trials targeted for 2026/2027. We recently raised €27M in Series A funding from Plural, Cherry Ventures, Kindred Ventures, and Brainlab, fueling our next phase of growth.</p><p>Now, as we scale, we are looking for a QARA Engineer to support the QARA team on deploying/managing the QMS system and ensure regulatory compliance for our products.<br></p><p>What you’ll do:<br></p><p><strong>Quality Activities</strong></p><p>• Participate in the deployment of the Quality Management System (QMS) at Robeauté through document writing (procedures, work instructions, forms and records) and definition of quality processes.</p><p>• Participate in the management of quality events (Change controls, nonconformities, CAPAs) in collaboration with all Robeauté departments.</p><p>• Support suppliers quality activities (selection, qualification and evaluation).</p><p>• Contribute to activities related to sterility assurance and environmental controls (bioburden, sterility testing, endotoxins).</p><p>• Participate in the preparation and execution of internal and external audits.</p><p>• Contribute to employee training on quality requirements and processes.</p><p>• Monitor and analyse quality KPIs, identify trends, and propose improvements.</p><p></p><p><strong>Regulatory Activities</strong></p><p>• Support product compliance with applicable regulations and standards (US and EU).</p><p>• Contribute to the preparation and maintenance of regulatory documentation such as technical documentation/technical files, labelling and IFUs.</p><p>• Support regulatory impact assessments related to design or process changes.</p><p>• Contribute to regulatory compliance monitoring (regulation/standards updates, regulatory intelligence, gap analysis).</p><p>• Assist in Post-Market Surveillance (PMS) activities and vigilance reporting.</p><p></p><p><strong>Collaboration</strong></p><p>• Collaborate closely with R&amp;D, Manufacturing, Product, Clinical teams to ensure compliance requirements are properly integrated.</p><p>• Provide operational-level quality and regulatory guidance.</p> <p><strong>Technical Skills</strong></p><p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Good knowledge of&nbsp;ISO 13485, 21 CFR part 820, EU MDR, Design Control principles, Risk Management (ISO 14971).</p><p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Understanding of regulatory requirements for class II/III medical devices in the US and EU.</p><p><strong>Personal Attributes</strong></p><p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Strong organizational and documentation skills.</p><p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Analytical and structured thinking.</p><p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Detail-oriented and rigorous.</p><p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Proactive and able to work autonomously.</p><p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Team-oriented and capable of working cross-functionally.</p><p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Strong written and verbal communication skills in&nbsp;French and English.</p><p><strong>Education and Experience</strong></p><p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Master’s or Engineering degree in Biomedical Engineering, Life Sciences, Quality and/or Regulatory Affairs.</p><p>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Minimum 2 years of experience in Quality and/or Regulatory Affairs within the medical device or regulated healthcare industry.</p> <p><strong>A Mission That Matters:&nbsp;</strong>join a team developing life-changing technology. Our microrobots have the potential to help over&nbsp;1 Billion patients with neurological conditions by providing unprecedented access and data.</p><p><strong>World-First Innovation: </strong>work on pioneering microrobots that navigate the brain for diagnosis and treatment—minimally invasive, maximum impact.</p><p><strong>An Exceptional Team:&nbsp;</strong>collaborate with leading engineers, clinicians, and researchers pushing the boundaries of medical robotics and neurotechnology.</p><p><strong>Real Ownership:</strong>&nbsp;join a well-funded deep-tech startup backed by top investors. Shape your domain, drive strategic decisions, and grow with us.</p><p><u><strong>Also</strong></u></p><p>Health Insurance &nbsp;— We happily cover 60% of the cost.</p><p>Meal Vouchers &nbsp;— €9.25 per day, 60% covered by the company.</p><p>Transportation Reimbursement &nbsp;— 50% of your commuting costs covered.</p>