Quality and regulatory affairs
The Company
Ummon HealthTech is a young medical technology start-up that develops predictive software for cancer. Using artificial intelligence and deep learning, we help pathologists to better identify and characterise cancer cells. We are not interested in mimicking the doctor, we want to augment him.
Founded in 2020, Ummon HealthTech is now a winner of the i-Lab 2022 competition for innovative technology company creation projects.
Ummon HealthTech is also ISO 13485 certified since 2021, only 1 year after its creation. Our offices are located in an innovation pole in Dijon, and we have already recruited a dynamic and international team (5 different nationalities). Our philosophy is simple: if you have ideas, don’t be afraid to express them! The company is built above all with its employees.
So, are you ready to join us?
The Job
As a Quality and Regulatory Affairs Engineer you will be responsible for the maintenance of our regulatory and quality files and for ensuring that they comply with the latest regulations in force.
Your tasks :
– Build the quality file and technical documentation related to the IVDR 2017/746 standard applicable to in vitro medical devices.
– Maintain the quality system according to ISO 13485 and the technical documentation according to IEC 62304.
– Prepare the adaptation of our quality system to FDA regulations.
– Ensure regulatory, quality and normative monitoring of the target systems.
About you
The skills required :
A mastery of the constitution and maintenance of quality management files
In-depth knowledge of medical device regulatory standards.
Experience in compliance with FDA regulations would be a plus
Experience in monitoring regulations and adapting the quality system to new standards
The profile we are looking for must demonstrate a high degree of rigour and autonomy with regard to a complex regulatory system, and must be able to adapt to rapid changes. He/she must also be able to communicate well, as it is by being in permanent contact with all the teams that he/she will be able to effectively maintain the quality system in relation to the company’s evolution.
More information
Keywords: IVDR, Quality, Regulatory, Medical device
Location: Dijon, telecommuting possible
Please send your application with a CV to: hiring@ummonhealthtech.com or via the form below