QA/RA Engineer

About Cercare Medical

Cercare Medical is an innovative company in the field of medical technology based in Aarhus. With a focus on advanced AI algorithms, Cercare assists doctors worldwide in accelerating the analysis of scan images, potentially saving lives. After achieving several FDA approvals and forming partnerships with prestigious medical institutions such as the Karolinska Institute, we find ourselves in an expansion phase, where we continue to strive to improve the quality and efficiency of our products.

About Cercare’s Department

As part of Cercare’s QA/RA team, you will work alongside 2-3 other regulatory experts. The team is closely connected to the development team and ensures that Cercare’s products meet the highest standards. With an employee base spread across multiple countries, you can expect a dynamic and international work environment.

About the QA/RA Engineer Position

As a QA/RA Engineer, you will play a central role in ensuring that Cercare’s products meet regulatory requirements worldwide. Serving as a bridge between our product development team and various health authorities, you will assist in navigating and adapting solutions for the different markets Cercare operates in.

Responsibilities as QA/RA Engineer

• Quality management and assurance of documentation
• Preparation and maintenance of clinical evaluations
• Market surveillance post-product launch and related activities
• Preparation of product documentation in accordance with regulatory requirements
• Close collaboration with development teams to ensure compliance with regulatory guidelines
• Continuous updates and adjustments of regulatory procedures based on market feedback and changes in legal requirements.
• Experience in quality management, clinical evaluation, post-market surveillance, and product documentation will be a significant advantage in this role.

Application and Contact
This recruitment is assisted by Capax Recruitment. If you would like to learn more about the position, please feel free to contact Aleksander Lundsted at alu@capax.dk.