QARA Engineer – Medical Devices (EU/US) & Quality

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 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.