Senior Quality & Regulatory Expert

Belval, Esch-sur-Alzette
CDI
Temps-plein

Il y a 2 mois
Postuler facilement

Have you ever thought to make a real impact on millions of lives? Join the dynamic team of PhDs, Engineers, and Q&R Specialists dedicated to revolutionizing spine surgeries with cutting-edge Software as a Medical Device (SaMD) technology.Your Mission:

Lead and Enhance Our QMS: Keep our Quality Management System (QMS) compliant with ISO 13485, ensuring top-notch quality and certification.
Drive Regulatory Compliance: Shape our regulatory strategy and ensure smooth market entry.
Secure Go-to-Market Authorization: Prepare and submit technical documentation for EU and USA regulatory approvals.
Foster Team Growth: Train and develop your team on QMS and regulatory standards, becoming an internal auditor.

Your Profile:

Key words: SaMD, FDA, CE Mark.
Experience: Proven Q&R expertise, successful regulatory authorizations in EU and USA, and team development skills.
Education: Master’s degree in Engineering (Quality, bio-mechanics, or equivalent).
Qualifications: Mastery of ISO 13485, MDR (EU), CFR (USA), risk management, usability, cybersecurity, and AI in SaMD. Internal auditor certification is a plus.
Technical Skills: Deep understanding of medical device regulations and proficiency with Office Suite.
Soft Skills: Fluent in English (French is a plus), excellent teamwork and communication, detail-oriented, and highly motivated.

Why Join Us?

Competitive Salary & Benefits: Enjoy a rewarding compensation package.
Work-Life Balance: Benefit from a healthy work-life balance.
Purpose-Driven Work: Make a direct positive impact on millions of lives.
Location: Full-time position in Belval, Luxembourg, with hybrid work options.

Ready to take the next step in your career? Apply now and be part of a team that's changing the future of spine surgery!

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