QARA Engineer

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.

We've developed microrobots capable of travelling inside the brain to collect biopsies, deliver cancer drugs, and implant electrodes for neurological treatments.

Since our founding in 2017, we've filed 50+ patents and successfully tested our technology in living animals, with human clinical trials targeted for 2027. We recently raised €27M in Series A funding from Plural, Cherry Ventures, Kindred Ventures, and Brainlab, fueling our next phase of growth.

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.

What you'll do:

Quality Activities

• 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.

• Participate in the management of quality events (Change controls, nonconformities, CAPAs) in collaboration with all Robeauté departments.

• Support suppliers quality activities (selection, qualification and evaluation).

• Contribute to activities related to sterility assurance and environmental controls (bioburden, sterility testing, endotoxins).

• Participate in the preparation and execution of internal and external audits.

• Contribute to employee training on quality requirements and processes.

• Monitor and analyse quality KPIs, identify trends, and propose improvements.

Regulatory Activities

• Support product compliance with applicable regulations and standards (US and EU).

• Contribute to the preparation and maintenance of regulatory documentation such as technical documentation/technical files, labelling and IFUs.

• Support regulatory impact assessments related to design or process changes.

• Contribute to regulatory compliance monitoring (regulation/standards updates, regulatory intelligence, gap analysis).

• Assist in Post-Market Surveillance (PMS) activities and vigilance reporting.

Collaboration

• Collaborate closely with R&D, Manufacturing, Product, Clinical teams to ensure compliance requirements are properly integrated.

• Provide operational-level quality and regulatory guidance.

Requirements

Technical Skills

·       Good knowledge of ISO 13485, 21 CFR part 820, EU MDR, Design Control principles, Risk Management (ISO

·       Understanding of regulatory requirements for class II/III medical devices in the US and EU.

Personal Attributes

·       Strong organizational and documentation skills.

·       Analytical and structured thinking.

·       Detail-oriented and rigorous.

·       Proactive and able to work autonomously.

·       Team-oriented and capable of working cross-functionally.

·       Strong written and verbal communication skills in French and English.

Education and Experience

·       Master's or Engineering degree in Biomedical Engineering, Life Sciences, Quality and/or Regulatory Affairs.

·       Minimum 2 years of experience in Quality and/or Regulatory Affairs within the medical device or regulated healthcare industry.

Benefits

A Mission That Matters: join a team developing life-changing technology. Our microrobots have the potential to help over 1 Billion patients with neurological conditions by providing unprecedented access and data.

World-First Innovation: work on pioneering microrobots that navigate the brain for diagnosis and treatment—minimally invasive, maximum impact.

An Exceptional Team: collaborate with leading engineers, clinicians, and researchers pushing the boundaries of medical robotics and neurotechnology.

Real Ownership: join a well-funded deep-tech startup backed by top investors. Shape your domain, drive strategic decisions, and grow with us.

Also

Alan Health Insurance  — One of France's most innovative health insurance providers. We happily cover 60% of the cost.

Meal Vouchers  — €9.25 per day, 60% covered by the company.

Transportation Reimbursement  — 50% of your commuting costs covered.