QA & Regulatory Affairs Manager

Dr Sharon Stapleton

Dr Sharon Stapleton has ten years experience in the IVD industry with both early stage start-ups and global diagnostics companies. Prior to joining OncoMark Ltd, she held the position of R&D Manager at EKF Diagnostics Ltd, a global medical diagnostics business with a long history in point-of-care and central laboratory test development and manufacturing. During this time she led numerous product development projects from design concept through to commercialisation, managed site transfers and evaluated new product and technology opportunities. In addition she established and managed an ISO 13485 certified manufacturing facility and assisted in the compilation of a number of technical files for regulatory approval in the EU (IVD Directive 98/79/EC) and US (FDA 510(k)) markets.
Sharon holds a degree in Biotechnology and a PhD in Applied Biochemistry from Dublin City University.

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