Tsz Fung Cheung Email & Phone Number

Trumbull, Connecticut, United States

Hong Kong

◦ Preparing regulatory dossiers for submission of voluntary product listing of medical devices and wholesale dealer licenses in Hong Kong ◦ Performing regulatory assessment for product changes and evaluating the impact on existing licenses and registrations ◦ Planning and Developing of regulatory strategies for new product launch and introduction ◦ Liaising with officials from the Department of Health (Drug Office & Medical Device Division), reporting on any safety alerts or post-market vigilance activities from regulatory agencies in other jurisdictions (US FDA, EU National Competent Authority, Australia TGA, Health Canada, Japan PMDA/MHLW) ◦ Managing registration and submission database for company’s entire product portfolio ◦ Monitoring for new ordinances, regulations and guidances in Hong Kong, translating any new regulatory requirements into workable and pragmatic plans for execution ◦ Providing Ad-hoc regulatory support and building positive relationships with both internal and external customers

Hong Kong

◦ Independently responsible for a total of 12 countries in Southeast Asia and Indian subcontinents ◦ Formulating regulatory strategies for general and IVD medical device products based on the national regulatory requirements of each country ◦ Working with both internal and external parties to facilitate new product launches ◦ Preparing regulatory submission dossiers (ASEAN CSDT) for new and existing products ◦ Assessing regulatory impact of product changes in responsible countries ◦ Reviewing of labeling and promotional material in responsible countries ◦ Post-market Reporting of AE and FSCA in responsible countries ◦ Keeping abreast of new regulatory changes to ensure continuing compliance in responsible countries

Hong Kong

◦ Obtaining product approvals & clearance for IVD medical device products, with a focus on EU ◦ Working closely with EU Notified Bodies through both in-person and paper-based audit ◦ Planning and Strategizing of regulatory pathways with the R&D team at the beginning of each project ◦ Preparing of regulatory dossiers (GHTF STED) for new and existing IVD products ◦ Reviewing of product manual, labeling, packaging and promotional materials ◦ Implementing and maintaining of the ISO 13485 quality management system by writing SOP (Standard Operating Procedure) and WI (Work Instruction) ◦ Conducting risk management activities (risk management plan, FMEA, Risk-benefit analysis) for new and existing products based on ISO 14971 principles ◦ Representing the company in industry groups such as HKMHDIA (Hong Kong Medical and Healthcare Device Industries Association) and ARPA (Asia Regulatory Professional Association)

Hong Kong

◦ Obtaining product approvals & clearance for IVD medical device products, with a focus on EU ◦ Working closely with EU Notified Bodies through both in-person and paper-based audit ◦ Planning and Strategizing of regulatory pathways with the R&D team at the beginning of each project ◦ Preparing of regulatory dossiers (GHTF STED) for new and existing IVD products ◦ Reviewing of product manual, labeling, packaging and promotional materials ◦ Implementing and maintaining of the ISO 13485 quality management system by writing SOP (Standard Operating Procedure) and WI (Work Instruction) ◦ Conducting risk management activities (risk management plan, FMEA, Risk-benefit analysis) for new and existing products based on ISO 14971 principles ◦ Representing the company in industry groups such as HKMHDIA (Hong Kong Medical and Healthcare Device Industries Association) and ARPA (Asia Regulatory Professional Association)

Hong Kong

◦ Leading and Participating in development activities related to new IVD products ◦ Planning and organizing of bench testing and clinical trials for the purpose of product design verification and validation ◦ Investigating deviations and divergence in the manufacturing and quality control process ◦ Maintaining the ISO 9001 Quality Management System by implementing document control and other continuous improvement initiatives ◦ Participating in the day-to-day manufacturing and quality control activities of IVD products

Hong Kong

◦ Leading and Participating in development activities related to new IVD products ◦ Planning and organizing of bench testing and clinical trials for the purpose of product design verification and validation ◦ Investigating deviations and divergence in the manufacturing and quality control process ◦ Maintaining the ISO 9001 Quality Management System by implementing document control and other continuous improvement initiatives ◦ Participating in the day-to-day manufacturing and quality control activities of IVD products

Bachelor Of Science (B.Sc.), Cell Biology And Genetics

Bachelor Of Laws - Llb

Education record