Quality & Regulations (Q&R) Specialist

Quality and Regulations Specialist
- Software as Medical Device (SaMD) Your mission is to join the team of PhDs, Engineers and Q&R Specialists dedicated to the development and commercialization of a Software as a Medical Device (SaMD) platform. This platform is aimed at helping Surgeons and Medical Device Designers to design, certify, and use innovative software to optimally plan and execute spine surgeries. You will work within a highly competent and motivated team whose purpose is to improve the quality of life of millions of patients around the globe by merging the latest and greatest in engineering technologies and medical sciences. Your Responsibilities 1. Own, Apply and Improve the Quality Management System (QMS)
• Ensure that the QMS is always up-to-date and always compliant to ISO 13485. Keep the ISO certification valid.
• Ensure that MDsim Management and Associates work is compliant with the QMS processes and guidance.
• Own internal and external audit planning and execution. Follow up on the actions as required. 2. Regulatory Compliance
• Contribute with Management to defining the Regulatory Strategy in line with the SaMD development and deployment. 3. Go-to-Market Authorization
• Contribute to building the technical documentation to submit to EU, USA regulatory authorities.
• Address other market authorizations in line with the product strategy 4. Self and Team Development
• Develop Self and Team on QMS and Regulatory items.
• Develop into an internal auditor.

Your Profile
Experience
• Proven experience in Q&R including QMS building and application.
• Experience as Head of Q&R in MedTech companies
• Experienced in setting and obtaining Regulatory authorization in EU and USA as well as other markets
• Experienced in developing team members on Medical Device Quality and Regulation Norms and Standards and related processes. Academic Background
· Master’s degree in Engineering preferably Quality, bio-mechanics, or Equivalent. Qualifications
• ISO 13485 expertise.
• MDR (EU) and CFR (USA) Regulation expertise.
• Risk Management expertise.
• Knowledge in Usability, Cyber Security is a plus.
• Knowledge in Artificial Intelligence application to SaMD is a plus.
• Internal auditor certification is a plus. Technical Skills
• Strong understanding of medical device regulations, such as ISO 13485 and MDR and CFR guidelines.
• Office Suite proficiency including Sharepoint. Soft Skills
• Fluent in English, being Fluent in French is a plus, additional languages welcomed.
• Excellent teamwork
• Excellent verbal and written communication.
• Great attention to details, organizational aptitude, and an analytical mind
• Highly motivated with a “can do” attitude. Additional Information Your work will be rewarded with a competitive salary, a complete benefit package, a good work/life balance and a sense of purpose with a direct positive impact on millions of lives. Full-time position, located in Belval (Esch-sur-Alzette), Luxembourg; on-site preferred, hybridization with remote work conceivable. To apply, please send your CV to dany.assaker@mdsim.health Legal Notice: By answering to this job posting and sending your résumé, you consent that the personal data of this résumé will be used by MDsim Management to contact you and arrange for interviews.