Ali Borazjani

Head of the Quality Assurance & Regulatory Affairs at Gendius

Ali Borazjani has had a varied career, beginning in 2005 as a Chemical Process Engineer at Qatargas and a Rally Driving Instructor at Desert Rally School. In 2007, they became a Design Engineer at Routec. In 2011, they took on the role of Development Engineer at ECCO Safety Group. In 2014, they were a Sr. NPD Project Engineer at Smith & Nephew. From 2017 to 2019, they were the Research & Development Lead at ConvaTec. In 2021, they became the Quality Improvement and Regulatory Affairs Manager at Genomics England. Currently, they are the Head of the Quality Assurance & Regulatory Affairs at Gendius Ltd.

Ali Borazjani completed their Bachelor of Science (BSc) in Chemical Engineering from Petroleum University of Technology between 2000 and 2004. Ali then went on to pursue their Master of Science (MSc) in Medical Engineering from the University of Hull between 2010 and 2011. Since then, Ali has obtained numerous certifications from various institutions such as SGS, WMDO - World Medical Device Organization, QCS International, Smith & Nephew, and ELPIS TRAINING LIMITED. These certifications include Medical Device Software Validation according to ISO62304, Medical Device Clinical Evaluation, Medical Device Post Market Surveillance and PMCF, The European Union Regulatory System for Medical Devices, 93/42/EEC Medical Device Technical File, Medical Device Lead Auditor, Medical Device Risk Management according to ISO14971, Process Validation, ISO 13485:2016 Lead Auditor, Medical Device Usability according to ISO62366, LEAN Organization Management, and Medical Device Clinical Evaluation.

Links

Previous companies

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Timeline

  • Head of the Quality Assurance & Regulatory Affairs

    June, 2022 - present

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