FeetMe is a digital health company developing innovative connected technologies and services to improve patient outcomes in functional care, track disease evolution, and optimize medication utilization.

The innovative technology from FeetMe allows gait and posture analysis in real-time and real-life conditions. The technology combines pressure sensors, motion sensors and learning algorithms to analyze patients’ functional capacity, as well as empower rehabilitation among sufferers of gait disorders.

Position description
FeetMe is looking for a Quality & Regulatory Affairs Engineer to help us maintain and further improve our quality standards and achieve regulatory compliance on all the desired markets. You will work with all FeetMe department to implement an efficient quality management system and obtain regulatory clearances.

Your missions will be :

➔ Participate in the maintenance of QMS for compliance with ISO 9001 and ISO 13485 and with regulations (21 CFR part 820, MDR 2017/745,…)
➔ Ensure continuous improvement of FeetMe processes and procedures
➔ Participate in internal and external audits
➔ Follow and participate in processing of complaints, non-conformities and CAPAs
➔ Organize and follow risk management activities
➔ Support Feetme teams to provide regulatory and quality assistance and participates in promotion of awareness of quality and regulatory requirements.
➔ Ensures that all documents (labelling, instruction of use…) are complying with applicable national & international regulations.
➔ Participate in the regulatory monitoring (UE regulation, guidelines, Standards, FDA regulation…) for the conformity of FEETME products.
➔ Perform standards and/or regulations gap assessments
➔ Creates and maintains regulatory files required for market access (FDA, EU technical file,…)

Required skills
We are looking for a talented profile with the following requirements :

➔ Engineer or equivalent, with a degree in quality or regulatory affairs
➔ Work experience as a QA/RA engineer in a medical device company
➔ Good knowledge of ISO 13485;
➔ Problem-solving mindset
➔ Excellent communication skills ;
➔ Team spirit ;
➔ Ability to deliver in a multi-projects environment

The following competences will be a plus :
➔ Experience with Regulation 2017/745 (MDR) or 21 CFR 820 (FDA)
➔ Experience with standards IEC 62304, IEC 62366-1 and ISO 14971

Reports to
The Quality & Regulatory Affairs Engineer reports directly to the Head of Quality & Regulatory Affairs.

HR interview
QARA interview
Team interview
CEO interview