Laurie Sang

About Laurie Sang

I am a seasoned Regulatory and Quality Affairs professional with over 15 years of experience in the medical device manufacturing industry. I have had the privilege of working with industry leaders such as Stryker, CR Bard, Becton Dickinson, and Philips, where I honed my expertise in both pre-market and post-market regulatory submissions.My skills include authoring 510(k)s, PMAs, Letters to File, Technical Files, Clinical Evaluation Reports, and Pre-Submissions. I bring extensive knowledge of FDA and international regulatory interactions, ensuring compliance and success in global markets.I thrive in dynamic, collaborative environments and am passionate about delivering excellence in regulatory and quality affairs. As I embark on the next chapter of my career, I am seeking remote opportunities that allow me to leverage my experience while contributing to the innovation and success of a forward-thinking organization.Let’s connect if you have opportunities or leads in regulatory and quality affairs, or if you would like to collaborate with a results-driven professional dedicated to advancing healthcare technology.

Experience

1. Sr Regulatory Affairs Manager

   LivaNova

   Mar 2025 — Present

Education

• Arizona State University

  Bachelor of Engineering - BE, Bioengineering and Biomedical Engineering

• Arizona State University

  Bioengineering, Biomedical/Medical Engineering

  1998 — 2005

Skills

• Quality Assurance
• Iso 13485
• Team Building
• Iso
• Fda
• Quality System
• Customer Service
• Complaint Management
• Medical Devices
• Sales
• Regulatory Affairs
• Capa
• Regulatory Requirements