CAREERS

Quality & Regulatory Affairs Assistant – Apprentice

Ready to learn fast and make an impact faster? In our agile team, you’ll tackle diverse challenges and turn your apprenticeship into a long-term career.

About Cardiawave

Based in Levallois-Perret, near Paris, Cardiawave SA is developing a non-invasive ultrasound therapy for the treatment of heart valve disease, with an initial focus on calcified aortic stenosis, the most common cardiac pathology in adults. Its patented technology combines therapeutic ultrasound, robotics, and ultrasound imaging. It is the result of research conducted by the French academic laboratories Physics for Medicine Paris (INSERM/CNRS/ESPCI/PSL) and Georges Pompidou European Hospital (HEGP), a leader in the field of valve disease and cardiac ultrasound imaging.

During the clinical investigation phase, Valvosoft® has been used to treat 100 patients in 4 european countries. Valvosoft received the CE Marking in November 2025 in the European Union and is not yet approved for commercial use in other countries or areas including the United States.

Cardiawave currently has 25 employees.

In accordance with applicable regulations, all our positions are open to people with disabilities.

The role

The new team member will participate in the activities related to quality & regulatory affairs.

The responsibilities are the following and other duties may be assigned:

• Participate in the management of non-conformities, CAPA, complaint.
• Participate in QMS documentation management.
• Ensure the update of quality & regulatory affairs dashboard.
• Participate in the constitution and maintenance of technical and regulatory files (technical files, authorizations for clinical studies, registration, etc.) by gathering and structuring the necessary elements.
• Participate to regulatory and standards surveillance.

The skills

• Apprentice in Quality and/or Regulatory affairs for Medical devices (Master degree)
• Concepts of quality management system (ISO 13845) & medical device regulation (EU MDR 2017/745).
• Knowledge of Pack office (Word, Excel).
• English (written and spoken).

Ready to grow with us? Please send your resume at jobs@cardiawave.com. We will definitively get back to you.

—————————————————————————————————————————–