I bring over 16 years’ experience in quality management and regulatory affairs to my role as a
Regulatory Consultant; I also have a degree in Microbiology and MSc in Environment and Human
Health. Having worked with many devices across several IVD and MD industries, I have hands-on
experience in quality management, IVDD, IVDR, MDD, MDR, CE Marking.
My responsibilities comprise of building technical files, and involves creating clinical evaluations,
biological evaluation assessments as well as supporting clients through their regulatory pathway