We are looking for a Quality Engineer and Regulatory Affairs specialist currently working and with at least 5+ years’ proven experience in medical device development (from design to market).
You must have a passion and deep understanding of QMS culture in MedTech industry; you will lead company ISO quality standards throughout clinical trials and markets expansion (FDA & MDSAP area).
TOKA surgical kit comprises a personalised (class 2b) implantable device and a mix of surgical CE marked and custom-made instrumentation. Therefore, a clear understanding of manufacturing process control in both areas is essential, preferably with knowledge in AM process.
The ideal candidate will also have the experience and ability to lead the process to certification of our surgical planning software in line with IEC:62304 standards and new MDR.