Throughout my career, I've been fortunate to work on products that have truly changed people's lives. The opportunity to work on projects that have the potential to transform healthcare continues to inspire me.

 

My BAckground

During my 30+ years in the life sciences and medical device industries, I have held positions in Product Development, Program Management, Alliance Management, and most recently, Regulatory Affairs. Before starting K2 Regulatory Consulting, I was Head of Regulatory Affairs at Illumina, where I built a global regulatory organization, with offices in China, Australia, and the UK. I also led the regulatory efforts to bring Illumina their first PMA product approval (Extended RAS Panel Test) in 2017.

I joined Illumina in 2014 as part of the acquisition of the consulting firm Myraqa. While at Myraqa I worked for 5 ½ years as a regulatory consultant, collaborating with my clients on a variety of projects in the areas of infectious disease, oncology, cognitive disorders and companion diagnostics.

Prior to that, I was Director of Program Management at both Adamas Pharmaceuticals and CareDx. I also worked for 7 years at Affymetrix, first in Program Management and later in Strategic Alliances Previous to that I worked at for 7 ½ years Chiron Diagnostics, where I was part of the product development team that launched one of the first HIV viral load tests, using Chiron’s bDNA technology.

I have a B.S degree in Biochemistry from San Francisco State University, and a MBA from San Jose State University. I also hold a RAC from the Regulatory Affairs Professional Society (RAPS).

Oh and I’m also an instructor at UC Santa Cruz Extension.

You can view and download my full curriculum vitae here.

What i've accomplished

  • Built and led a global regulatory organization that was responsible for filing and maintaining product registrations and approvals in over 30 countries.

  • Worked on numerous IVD projects, contributing everything from strategic plans to writing and coordinating regulatory submissions in the US, Canada, Europe, and key markets throughout Asia.

  • Trained multiple organizations on quality systems and medical device regulations, lectured extensively on regulatory topics, and authored book chapters and articles on the subject.

  • Developed quality systems in several organizations which have ultimately withstood the rigors for FDA, ISO and MDSAP inspections.

  • Served as project lead for Quality System gap analysis and remediation projects.

  • Led geographically dispersed, cross-functional project teams in both regulated (ISO, FDA) and life science research industries to successful product launches in US and ROW.

  • Developed versatile, ISO compliant governance structures for working with large and small business partners in a regulated environment.

Photo by Yang Song