Hui Huang

Senior RA Manager

Chaoyang District, Beijing, China

About

- Strong research abilities both independently and team-working; - Strong interpersonal skills including communications, analysis, problem solving and leadership; - Strong adaptability to new environment, willing to work under pressure.

Experience

  • Senior RA manager at 贝朗医疗(上海)国际贸易有限公司
    Jul 2023 - Present · 3 yrs 1 mo

  • RA Manager at Baxter International Inc.
    Jan 2019 - Aug 2023 · 4 yrs 8 mos

  • GE Healthcare (7 yrs 7 mos)
    • Regulatory Affairs Leader
      Nov 2017 - Jan 2019 · 1 yr 3 mos

    • Lead QA Engineer
      Jun 2015 - Nov 2017 · 2 yrs 6 mos

      -- Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility. -- Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy to ensure compliance. -- Supports continuous product and process improvement through detailed failure analysis for non-conformance, and investigates, develops and implements effective and compliant solutions for CAPA actions. -- Manage internal and external audits to ensure compliance as required by business and regulatory agencies with high professional skills -- Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.

    • Firmware Engineer
      Jun 2013 - Jun 2015 · 2 yrs 1 mo

      -- Responsible for data Acquisition/control subsystem firmware design (CT Table) with compliance of GE product development process -- Interfacing with program and other function teams to line up the development progress -- Responsible for defining and executing validation plan to ensuring the quality of the design -- Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible