Meak Nget

About Meak Nget

A professional with extensive experiences in regulatory compliance industry. Highly skilled in reviewing, planning, writing procedure, guidance on risk assessment and gathering specifications. Strong working knowledge of regulatory regulations and knowledge of products testing in compliance with-national and international regulations. Proven leadership experiences in a fast paced, highly regulated environment. Possess strong problem solving and analytical abilities.

Experience

1. Design Quality Engineer Iec Regulatory Compliance Engineer

   飞利浦

   May 2022 — Present · Carlsbad, CA, US

   Collaborate, contribute and support R&D team. Provide quality engineering expertise for new product development as well as certain changes to existing commercially released product in the areas of Risk Management, Design Control, Usability Engineering, Design Verification, and Regulatory Compliance as needed.Experience with certification bodies and provides support for various product certification agencies, such as CSA, ETL and external laboratories to obtain product safety and EMC certification to applicable product safety and EMC standards (IEC 60601-1, IEC 60•••12, IEC 60•••16, IEC 60•••18, IEC 60••••12, ISO 80••••12, ISO 13485, ISO 14971, IEC 62304, and IEC 62133-2 etc.Participates in problem solving activities related to design, manufacture and test including CAPA, and supplier related issues.Providing guidance on the implementation of various regulatory process improvement projects and collaborating directly with key stakeholders in all business departments and functional groups as well as international counterparts to accelerate market access routes and ensure compliance.Good knowledge and understanding of global regulations relevant to medical devices (product registration, Unique Device Identification (UDI), 21CFR 801/ FDA Labeling Guidance and Medical Device Regulation (MDR 2017/745).Good understanding and knowledge of labeling guideline for medical devices, Product Safety Risk Management, Regulatory agency and Notified Body processes and interactions, RoHS and EU MDD/MDR Verification process.

Education

• Keller Graduate School of Management

  Master of Project Management (MPM)

  2011 — 2013

• DeVry University, Long Beach, CA

  Bachelor of Applied Science (B.A.Sc.), Business and Technical Management

  2008 — 2011

Skills

• Project Management
• Test Automation
• Product Safety
• Test Planning
• Spectrum Analyzer
• Rf
• Medical Compliance
• Root Cause Analysis
• Program Management
• Management
• Ce Marking
• Test Equipment
• Iso 17025
• Risk Management
• Cross-Functional Team Leadership
• Troubleshooting
• Engineering
• Aerospace
• Quality Assurance
• Iso Standards
• Emc Compliance
• Testing
• Leadership
• Pcb Design
• Quality Management
• Risk Assessment
• Fmea
• Iso
• Product Certification
• Electronics
• Ul
• Radio Frequency (Rf)
• Calibration
• Quality System
• Iec
• Engineering Management
• Electromagnetic Compatibility
• Rohs
• Product Development
• Test Engineering