Eric Lam Email & Phone Number

Hong Kong

香港特別行政區

Responsibilities include quality/regulatory compliance, product compliance, Product quality management and budget administration.Managing AP medical device regulatory affairs and quality expert.• Manage Complaint and CAPA (Corrective Action and Preventive Action)• Manage class I and II medical device registration in AP countries (China, Hong Kong, Korea, Taiwan, Singapore, Malaysia, Japan etc…), that provide the technical document support and manage the schedule including the Artwork, Sample and Launch status etc…• Establish After Sale Center to fulfill local regulation (Korea)

Ensure products comply with Regulatory requirements. Provide professional knowledge in both the regulatory requirement and the compliance process. Hayco is a manufacturer with varies type of products, including the floor care, baby care, beauty, toothbrush, drinking bottles/pitcher etc. They are categorized as different types of Regulatory requirements, such as medical device, food contact, electrical, chemical etc. I am managed all of these requirements and make sure the products complying with the requirements. Also, built an regulatory database in Hayco that contains all of these requirements for different products. In the product development stage, I provide the interpretation of the regulatory requirement, and how to comply with the requirement. This can ensure the product comply with the requirement in the first submission. Create compliance process is to ensure the submitted products comply with the regulatory requirement. Managed FDA registration and most of the country compliance process. Also, managed the product comply with individual country approbation before product launch. After production started, need to manage the compliance process with the customer. For example, the European REACH requirement. And, worked with the Procurement and suppliers to collect all the testing reports. The reports were uploaded to the 3rd parties system called BOMcheck as an evidence for the compliance of the European REACH requirements.

Hong Kong And China Shenzhen

Responsibilities include quality systems implementation, quality/regulatory compliance, quality auditing, product compliance, supplier control and budget administration.Managing AP medical device regulatory affairs and quality expert.Qualify and Managing the China suppliers, In order to fulfill the Company, Brand and Customer requirement.• Establish and Maintain ISO13485 Quality System for Shenzhen office which has run very well for 4year until present, the system is related to medical device• Apply Document Control procedure in AP region, which support the Global Quality Management System• Manage Complaint and CAPA (Corrective Action and Preventive Action)• Manage class I and II medical device registration in AP countries (China, Hong Kong, Korea, Taiwan, Singapore, Malaysia, Japan etc…), that provide the technical document support and manage the schedule including the Artwork, Sample and Launch status etc…• Establish After Sale Center to fulfill local regulation (Korea)

- Handle listing project evaluations according to EN, BSEN, IEC standards.- Reviewer trainee.- Design testing plan for testing engineer.- Conduct tests on quality performance of various household appliances- Issue report for the product conformity- Holding technical meeting with the clients- Handle the (Storage Water Heater) Energy Efficiency test for CLP & EMSD.- Design a performance test and comparison test of Dehumidifier and instant-heat water heater for CLP.