QARA Engineer

Robeauté; Paris; On-site; EUR 55,000 - 85,000; Full time

Benefits offered by this job

Mission that matters

World-first innovation

Exceptional team

Ownership opportunities

Health Insurance

Meal vouchers (€9.25/day)

Transport reimbursement

Job summary

Robeauté is advancing neurosurgery with microrobots and is seeking a QARA Engineer to deploy and manage the QMS system, ensuring compliance for US and EU markets. You will work across R&D, manufacturing, and clinical teams to maintain regulatory readiness, author technical documentation, and support audits.

We value rigorous, autonomous individuals with strong organizational skills and fluency in French and English.

Qualifications

• Master's or Engineering degree in Biomedical Engineering or Regulatory Affairs.
• Minimum 2 years of experience in Quality and/or Regulatory Affairs within the medical device or regulated healthcare industry.
• Strong written and verbal communication in French and English.

Responsibilities

• Deploy and manage QMS documentation (procedures, work instructions, forms, records).
• Support quality events: CAPAs, deviations, changes, nonconformities.
• Collaborate with R&D, Manufacturing, Product and Clinical teams to ensure compliance.
• Assist in regulatory documentation and submissions (technical files, labeling, IFUs).
• Contribute to audits (internal and external) and training on quality requirements.

Skills

Regulatory alignment

Quality systems

Documentation

Audit readiness

Cross-functional collaboration

Education

Master's or Eng. degree in Biomedical Engineering/Regulatory Affairs

Tools

ISO 13485

21 CFR 820

EU MDR

Design Controls

ISO 14971

Job description

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 2026/2027. 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 14971) 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.
• AlsoHealth Insurance — 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.