39 min
Developing skills in the last place you'd expect | Steve Lee, Director of Diagnostics Regulation, ABHI Career Diaries by Elemed
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- Careers
Key takeaways:
Learn about IVDR from MR IVD himselfWhy we can all be INSPIRED by the healthcare industryThe VALUE of having a hands-on backgroundWhy you should find your DRIVE from unlikely sources
About Steve Lee:
Steve joined ABHI as Director of Diagnostics Regulation in 2020.
After completing his degree in Biochemistry and Biology at Aston University, Steve trained as a Biomedical Scientist, working in hospital microbiology before moving to industry to work as company microbiologist. Steve joined MHRA in 1996 when it was still the Medical Devices Agency and when the IVD Directive had yet to be implemented.
While at MHRA, Steve worked with manufacturers, Notified Bodies, other Competent Authorities, Trade Associations, standards bodies, and government departments. Steve was Chair of the European Commission’s IVD working group when the IVD regulations were being developed.
In 2019, Steve was presented with the TOPRA award for regulatory excellence.
Key takeaways:
Learn about IVDR from MR IVD himselfWhy we can all be INSPIRED by the healthcare industryThe VALUE of having a hands-on backgroundWhy you should find your DRIVE from unlikely sources
About Steve Lee:
Steve joined ABHI as Director of Diagnostics Regulation in 2020.
After completing his degree in Biochemistry and Biology at Aston University, Steve trained as a Biomedical Scientist, working in hospital microbiology before moving to industry to work as company microbiologist. Steve joined MHRA in 1996 when it was still the Medical Devices Agency and when the IVD Directive had yet to be implemented.
While at MHRA, Steve worked with manufacturers, Notified Bodies, other Competent Authorities, Trade Associations, standards bodies, and government departments. Steve was Chair of the European Commission’s IVD working group when the IVD regulations were being developed.
In 2019, Steve was presented with the TOPRA award for regulatory excellence.
39 min