We have worked for 2 years on our technology and product. Now is the time to start working on our go-to-market, for which Quality & Regulatory activities are essential. We’re looking for that special resourceful, driven, highly effective someone who’ll make our QMS, FDA approval and CE mark a reality, with the full support of the executive team and the R&D team.

Your mission can be summarized as “co-define, drive and execute on a fast-track quality & regulatory strategy”

This may comprise (non exhaustive list, you probably know better what may need to be done…)
• Initiate & drive discussions with regulatory authorities (with ad hoc consultants as the case may be)
• finalize the Clinical Evaluation
• Manage system and product risk management processes
• Review & help prepare the technical documentation until and after submission to regulatory authorities.
• Structure, write, record and implement the company’s Quality Management System
• be responsible for the regulatory watch and new regulations enforcement
• Prepare & organize management reviews, quality reviews as well as team’s quality trainings
• Validate equipment, softwares and processes
• Organize internal & external audits
• potentially at some point : build your own team

What we look for :
• at least 3 years experience in Quality or Regulatory affairs, preferably 5+
• Knowledge of the American and European regulatory landscapes for a medical device.
• Experience in setting up a QMS, a technical documentation and / or a 510(k) application.
• Good communication skills and ability to work independently within a highly-motivated and multidisciplinary team environment
• Ability to exert leadership and to get things done without formal authority
• Fluent English (C1)
• Desire to work in a fast-paced - frequent feedback start-up environment

What would be a cherry on the cake :
• Project management experience
• A significant experience in orthopedics and/or computer assisted surgery
• Knowledge of ISO 62304, 62366 and 60601

Miscellaneous:
• Our offices are located within a hospital. We’ve got a sunny terrasse and a flexible remote work policy.
• International applications with authorization to work in France are welcome