Elaine G. Taine
Dr. Taine, after training in clinical medicine, had devoted herself into biomedical research for many years focusing on functionality of factors that impacting the transcription and translation of DNA to protein, and various structure-function relationship of proteins, as well as impact of protein-protein interactions to various biological phenomena. Sensing a great need in translating the brilliant ideas and research results into useful tools to improve life, Dr. Taine started the journey in becoming an expert in IVD product development, preparing and taking products through the rigorous processes of regulatory approval. To give back to the community that has enriched her with the experience and expertise, Dr. Taine has dedicated her time and efforts in serving the research and medical device/IVD developers and manufacturers in various ways:
* Product life-cycle management: establishment, improvement and audit of quality management system (QMS) compliant to ISO 13485 and FDA 21CFR Part 820 QSR / QMSR; QMS audits include internal audits, supplier audits, mock ISO 13485 certification and surveillance audits, mock FDA inspections, mock FDA BIMO audits, and mock MDSAP audits; device FDA clearance and approval, MDR/IVDR CE Mark in the EU; establishment/facility registration and product listing with the FDA; product post-market management.
* Biomedical research and product development, e.g. IVD assay development using para-magnetic microparticles coupled with chemiluminescent detection and integrating to fully automated platform; Allergen material characterization and optimization; co-authored many patents for the innovations in biomedical research, assay chemistry, assay architecture and automation.
* Establishment and operation management of US subsidiary company, compliant to US federal, state and local regulations and requirements, e.g. HOB Biotech Group USA and AdvanBio Inc., the subsidiaries of international IVD manufacturers.
* Project management, talent recruit, leadership, people development, people management, team building.
Dr. Taine has worked with companies and organizations such as Thermo Fisher Scientific, SiPhox, Jacobs Institute, CLSI, Autobio Diagnostics, Lumigenex, as well as many other MD/IVD developers and manufacturers from the US, Canada, UK, France, Germany, South Korea, and other international territories.