Quality and Regulatory Engineer :
FDA/CE certification
Starting Date: Now
Position: Full-time / CDI
Location: Bordeaux, France
Keywords: Echocardiography, Medical device, Software, FDA, ISO 13485, EN 62304
Education: BSc/ MSc Formation in Software Development or similar
Context:
DESKi, “learn” in Breton, is a young and innovative company, combining a strong expertise in both echography and artificial intelligence. After 4 years of research, we developed real-time AI-driven algorithms able to guide operators performing cardiac ultrasound.
DESKi is now building HeartFocus to empower any healthcare professional to accurately perform a cardiac ultrasound exam and support the interpretation of the acquired US images.
Mission:
As a member of DESKi Team, you will be in charge of implementing the quality system of DESKi following the norm ISO 13485 and obtaining first the FDA certification and then the CE certification. For the certification and the regulatory affairs, DESKi will be supported by an external and specialized company.
Requirements:
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5y+ experience in quality and regulatory development
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Experience in FDA/CE certification
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Experience in ISO 13485 (including EN 62304)
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Quality and Regulatory of medical Software
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Proficiency in English
Desired skills:
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Experience in agile development
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Experience in GDPR
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Informatics background
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Medical Background
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Understanding of ML/AI
Your application should include
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a short introduction
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CV
Recruitment process
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Phone screening
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Interview with the lead R&D
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Interview with the CTO
To be sent to recruit@deski.io
Please reach out if you have any questions!