Tiffany Fan Lin

Tiffany Fan Lin started their career in 2012 as an Internship - Project Assistant at Ngee Ann Polytechnic, where they assisted the project PI on the discovery of novel fungal strain to convert cellulosic biomass into energy-rich fuels with high efficiency. Tiffany then moved on to become a Design and Development Officer at the same institution in 2013, working with a multi-institutional research team on novel diagnostic platform development project. In 2016, they joined StratifiCare Pte. Ltd. as Co-founder and Chief Regulatory Officer, where they were appointed Quality Management Representative for ISO 13485 QMS. Tiffany established and maintained the QMS for the design and development of medical devices, that were in compliance with EN ISO 13485: 2016, EU IVDR and US FDA 21 CFR Part 820. Tiffany also led the StratifiCare team to obtain its ISO 13485 certificate from TÜV SÜD PSB and achieved zero nonconformity for the surveillance audit in 2018.

Tiffany Fan Lin holds a Bachelor's Degree in Biochemistry and Molecular Biology from The University of Western Australia, which they obtained between 2013 and 2016. Prior to that, they obtained a Diploma in Molecular Biotechnology from Ngee Ann Polytechnic between 2010 and 2013. Tiffany also holds a number of certifications, including a Regulatory Affairs Certificate from RAPS ONLINE UNIVERSITY CERTIFICATE PROGRAM (obtained in June 2022), a Lean Six Sigma Foundation (Yellow Belt) from NUS SCALE-Lean Methods Group (obtained in December 2019), Excel: Statistical Process Control from LinkedIn (obtained in July 2019), Six Sigma Foundations from LinkedIn (obtained in July 2019), Medical Devices - Quality Management Systems Auditor/Lead Auditor Training Course (ISO 13485:2016) from BSI (obtained in November 2016), Epidemiology: The Basic Science of Public Health from Coursera Verified Certificates (obtained in October 2015), and a RAPS Member from Regulatory Affairs Certification Program (obtained in November 2019).