Boston-based biotechnology company, NanoMosaic Inc., has announced the appointment of Raaj Venkatesan as its Chief Regulatory Officer.
Raaj Venkatesan brings more than 17 years of experience in regulatory affairs, regulatory compliance and quality engineering in the medical device and In Vitro Diagnostics industry. Prior to joining Nanomosaic, Raaj served as a Regulatory Affairs and Quality executive at NovaSignal Corporation, Ancestry Health, the healthcare division of AncestryDNA and Exosome Diagnostics. Prior to that, Raaj held various regulatory affairs and quality engineering positions at Bio-Rad laboratories, Bruker Daltonics, OmniGuide Surgical, Becton Dickinson (BD) Diabetes Care and Second Sight Medical Products and has obtained multiple FDA clearances, European CE mark and Health Canada licenses. Raaj is Regulatory Affairs Certified (RAC-US, RAC-EU) by the Regulatory Affairs Professionals Society (RAPS) and is also an ASQ Certified Manager of Quality, Reliability Engineer, Quality Auditor, Biomedical Auditor and Quality Engineer.
He earned his Master’s Degrees in Biomedical Engineering, Electrical Engineering and Medical Device and Diagnostic Engineering from the University of Southern California and Bachelor’s Degree in Electronics and Instrumentation Engineering from Bharathidasan University in India.
“I am honored and excited to join Nanomosaic at such an exciting time for the company and the proteomics space,” said Raaj Venkatesan. “With the assays that we are developing with our current Tessie system and the nanoneedle technology, I look forward to working closely with our team, customers and appropriate regulatory agencies to ensure the most effective deployment of our technology to clinicians and pharmaceutical organizations. Additionally, I am particularly eager to leverage our recent partnerships with academic and clinical researchers to overcome obstacles in the regulatory and commercialization processes, and bring their assays as diagnostics to patients in need.”
“The reliability of the Tessie system, with over 99% uptime, a streamlined fully integrated workflow on standard liquid handling systems, and the fastest sample turn around time (from blood to answer), makes the Tessie an ideal platform for clinical applications,” stated John Boyce, President and CEO of NanoMosaic, as well as Co-founder of Tiger Gene Ventures. “NanoMoasic is committed to working closely with the FDA, as well as the appropriate additional regulatory agencies to ensure the the highest level of rigor in its processes and products. We are thrilled to have a creative veteran such as Raaj join the company as Chief Regulatory Officer to lead the clinical approval effort that will bring more predictive tests to the market in order to significantly improve patient care,” Boyce concluded.
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