beBee background
Professionals
>
Pharmaceutical / Bio-tech
>
Singapore
Hui Min Tan

Hui Min Tan

Quality Assurance/ Regulatory Affairs Manager
Singapore

Social


About Hui Min Tan:

I register medical devices for IVD DIRECTIVE 98/79/EC and Regulation (EU) 2017/745 for their distribution with the European Union Notified Bodies (EU NB).

I also build, implement and maintain the quality management system for medical devices system and obtained certification for ISO 13485:2016 and EN ISO 13485:2016.

Experience

I build, implement and maintain the quality management system for medical devices system and obtained certification for ISO 13485:2016 and EN ISO 13485:2016. As a certified ISO 9001:2015 Lead Auditor and certified ISO 13485:2016 Internal Auditor, I prepared and reviewed standard operating procedures for both internal and external audits. I maintained compliance with the requirements of GDPMDS SS620:2016 for distribution of medical device in Singapore.

I register medical devices for IVD DIRECTIVE 98/79/EC and Regulation (EU) 2017/745 for their distribution with the European Union Notified Bodies (EU NB).

Education

Nanyang Technological University,

Bachelor of Engineering (Honours (Merit)), Bioengineering 2016 – 2020

Professionals in the same Pharmaceutical / Bio-tech sector as Hui Min Tan

Professionals from different sectors near Singapore

Other users who are called Hui Min

Jobs near Singapore


  • HCL SINGAPORE PTE. LTD. Singapore $80,000 - $120,000 per year

    Roles & Responsibilities · Responsibilities: · Responsible for the overall health, performance, and capacity of VMware Cloud Foundation platform. · Understanding of NSX-T for configuration and using NSX-T for incident troubleshooting. · Able to use and configure hardware alerts u ...

  • Unison Consulting Pte Ltd

    IT Project Manager

    1 week ago


    Unison Consulting Pte Ltd Singapur, Singapore Full time

    Client facing project manager with 8+ years of experience in platform change and transitions. Candidate having experience in Wealth products, funds in particular will stand out. · Requirements · 5+ relevant experience in change management or migration projects (Client facing) · ...

  • WHITBY WOOD MILLS PTE. LTD.

    Design Associate

    1 week ago


    WHITBY WOOD MILLS PTE. LTD. Singapore

    Roles & Responsibilities · A world in crisis and needs a different kind of thinking. At Whiby Wood Mills, we fuse design, engineering, and a systems philosophy to push the boundaries of what is possible. We fully embrace the changing landscape of digital tools, R&D and dynamic wo ...