Quality and Regulations Specialist – Software as Medical Device

About MDsim

MDsim is a MedTech start-up based in Luxembourg advancing the field of in-silico medicine. Our main product, SPINEsim, is a Software as a Medical Device (SaMD) designed to transform spine health and improve the planning of surgical procedures. By combining advanced computer modeling and simulation (CM&S) with the power of data science and AI, we create digital twins of the spine to support clinical decisions. Our mission is simple yet ambitious: to bring proven technologies into healthcare and improve the quality of life of patients with spinal deformities worldwide.

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 Esch-sur-Alzette, Luxembourg; on-site preferred, hybridization with remote work conceivable.