Experience

VUNO Inc.

• South Korea
• Medical Device
• 1 - 100 Employee

• Head of RA Department

  • Aug 2021 - Present

  Responsible for overall Clinical trial//RA//QA process management of the VUNO 1. Multi-national Clinical Trial as per SIT & IIT 2. Country specific product registration process 3. QA & RA process management 4. QMS management 5. Business planning from the RA aspect 6. Authorities advisory and consultative body activities

• Head of RA team

  • Nov 2020 - Aug 2021

  Responsible for overall Clinical trial//RA//QA process management of the VUNO



LVMH Perfumes & Cosmetics

• Cosmetics
• 700 & Above Employee

• Regulatory Compliance Manager

  • Jan 2020 - Nov 2020

  1) In charge of Compliance management of LVMH => Cosmetics-focused Compliance activities => On-site audit responses (Local GMP & manufacturing site in EU)2) Responsible for Government relationship (MFDS & MoE) => Monitoring & reporting regulation updates => Change notification => Gap analysis3) In charge of Product registration process management => Internal process controlling & monitoring for Cosmetics, Chemical & industrial goods4) Responsible for Internal compliance audit for LVMH => Audit process management as Lead auditor => Risk assessment



TÜV SÜD

• Germany
• Public Safety
• 700 & Above Employee

• QMS Auditor

  • Jun 2015 - Jan 2020

  1) Medical Devices QMS Auditor :* Responsible for QMS assessment of EN ISO13485/MDSAP & CE marked devices2) Non-active Medical Device Team Leader* Responsible for project management, audit team resource management, customer management 1) Medical Devices QMS Auditor :* Responsible for QMS assessment of EN ISO13485/MDSAP & CE marked devices2) Non-active Medical Device Team Leader* Responsible for project management, audit team resource management, customer management



Novo Nordisk

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• 과장

  • Mar 2008 - Jun 2015