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Senior Quality & Regulatory Expert
Digital PiplBelval, Luxembourg, LuxembourgIl y a 8 jours
Description de posteKey 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. 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.
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 :
Why Join Us?
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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Senior • Belval, Luxembourg, Luxembourg