Regulatory Affairs Project Manager
December 2012 to April 2016
San Jose, CA
Sr. Regulatory Affairs Associate
July 2007 to December 2012
Graduate Student Researcher
September 2003 to June 2007
Los Angeles, CA
Senior Director of Regulatory Affairs
Redwood City, CA
June 1999 to August 2003
As an individual contributor, I serve as the regulatory affairs core team lead to provide high level regulatory guidance and support including design verification, validation, and clinical studies. I create and execute regulatory strategies for US and global registrations/compliance to gain approvals for commercial distribution and clinical research. In addition, I coordinate and prepare complex regulatory 510(k)... As an individual contributor, I serve as the regulatory affairs core team lead to provide high level regulatory guidance and support including design verification, validation, and clinical studies. I create and execute regulatory strategies for US and global registrations/compliance to gain approvals for commercial distribution and clinical research. In addition, I coordinate and prepare complex regulatory 510(k) submissions to FDA as well as prepare EU IVDD Technical Files for IVD systems (instrument, software, and reagent). I participate in business interactions and negotiations with regulatory agencies on pre-market submission requirements, labeling claims, and more. I organizes and manages meetings with regulators, including development of agenda and preparation of the attending company personnel. I lead proactive and continuous improvements for RA as well as review and approve promotional materials, experimental designs, data analysis, and product labeling as they relate to registration and commercialization of medical devices. In addition to being technically savvy, I understand and make decisions regarding a wide array of complex scientific and logistical issues.
What company does Katie Bessette work for?
Katie Bessette works for BD Biosciences
What is Katie Bessette's role at BD Biosciences?
Katie Bessette is Regulatory Affairs Project Manager
What industry does Katie Bessette work in?
Katie Bessette works in the Biotechnology industry.
💼 Past Experience
I am a graduate student researcher with experience in regulatory Affairs,Senior Director of Regulatory Affairs at Guardant Health, and Research Associate at Stanford University.
Katie Bessette has a PhD from the University of California, Los Angeles in Bioengineering. The PhD is in the area of Cell Biology. Bessette also has a BS from the University of California, Santa Barbara in Molecular Biology.
💡 Technical & Interpersonal Skills
Overall, my work experience has included a broad range of responsibilities in the regulatory Affairs field. I have experience in designing molecular signaling pathway studies, managing regulatoryisle efforts, providing support for translational Clinical Trials, and coordinate with regulatory agencies to bring products to market. I am also skilled in managing difficult conversations and managing deadlines.
Extraversion (E), Intuition (N), Feeling (F), Judging (J)
4 year(s), 3 month(s)
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