Carmen Lam

About

I am a Regulatory Affairs and Quality Assurance professional with over 20 years of experience across medical device, biotechnology, pharmaceutical, wellness, and cosmetic industries. Skilled in developing and executing regulatory strategies, preparing US and international submissions, and managing worldwide product registrations to support successful commercialization and market expansion. Experienced in building and maintaining compliant quality systems aligned with applicable regulatory requirements, including support for internal audits and regulatory inspections.

Experience

• Glacial® Skin by R2 Technologies, Inc. (9 yrs 1 mo)
  • Sr. Manager, Worldwide QA/RA
    Jun 2022 - Present · 4 yrs 1 mo

  • Manager Worldwide, RA/QA
    Oct 2019 - Jun 2022 · 2 yrs 9 mos

  • Staff Regulatory Affairs Specialist
    Jun 2017 - Oct 2019 · 2 yrs 5 mos

• Staff Regulatory Affairs/Quality Assurance Specialist at Eargo
  Dec 2015 - Jun 2017 · 1 yr 7 mos

• Sr. Regulatory Affairs Specialist at myoscience
  Sep 2014 - Dec 2015 · 1 yr 4 mos

• Sr. Regulatory Affairs/Quality Assurance Specialist at Arstasis
  Oct 2010 - Sep 2014 · 4 yrs

• Sr. Quality Engineer at Boston Scientific
  Aug 2008 - Oct 2010 · 2 yrs 3 mos