Graduate Certificate in Medical Devices Regulatory Affairs

Faculty

External professionals

 

Mr. Cai Yiting

Yiting has been working as a Regulatory Affairs professional since 2007, with experience across various product categories in the medical device industry. He started his career with Health Sciences Authority and is extensively involve in the creation of the various operational requirements and guidance necessary for the implementation of the Medical Device Regulations in Singapore. Yiting joined the industry in a Regional role from October 2010 and has since held increasing responsibilities in Quality & Regulatory Affairs, overseeing various markets in the Asia Pacific region (including, Australia, China & Japan). In addition to his existing responsibilities, Yiting is actively involved in regional regulatory harmonization and training initiatives, through his roles and appointments in AHWP Technical Committee, APACMed RA Committee and Regulatory Affairs Professionals Association (RAPro) Singapore.

 

Mr Chu Kia Moh

Mr Chu had been the Asia Pacific Regulatory Affairs and Quality Regional Head since 2003 to 2015 for Siemens Medical Instruments (SMI), a Hearing Aids manufacturer of Siemens Healthcare group which was later renamed Sivantos Hearing Company. It is a global company with HQ status in Singapore involving R&D, Manufacturing and Supply Chain/Distribution activities of hearing aids in compliance to ISO 13485,21 CFR Part 820 Class 2 Medical device requirements in US market and to European market too on MDD (Medical Device Directive).

A veteran Quality engineer that has been in the Quality field for the past 35 years, he started in the early 80s at Fairchild Semiconductor as a young Quality engineer. His exposures and experiences in the electronic and electrical components or instruments manufacturing sectors in compliance to the early days of regulatory requirements are wide and highly treasured. Mr Chu developed the company into its current status of being one of two design / R&D centres globally in hearing aids and as well as the Global HQ for its worldwide R&D/Manufacturing/Distribution activities.  He is very active in training / cultivating new hires in the Quality / RA field as he is very keen to pass on his wide exposures and experiences for the past 35 years to new blood. This has been demonstrated and welcome in the past 3 years as guest speaker to the MDRA programme.       

 

Mr Eric Chin SL

Eric Chin is the APAC Regulatory affairs Manager in 3M Health Care. His role is to provide regulatory guidance and quality system leadership to 3M subsidiaries in APAC in support of this business.
 
Eric has more than 15 years of experience in the medical device industry in different multi-national companies, manufacturing medical devices. His experiences spans across different functions and device risk levels. Functions ranges from medical device manufacturing and operations, plant and supply quality management, auditing, R&D (design control). Last but not least regulatory affairs in both pre and post market activities.

Eric plays an active part in the Asian Harmonisation Working Party's work group; (WG02 – Post Market Surveillance) and several industrial association in Singapore, with the aim to work with the regulators to enable patients to receive the latest and safest device available. He is currently involved with Advamed in planning training for countries in the South East Asia nations.

 

Ms Jacqueline Monteiro

Jacqueline has more than twenty (20) years of direct medical device industry experience in new product development, manufacturing operations, Quality Management Systems, and Regulatory Compliance activities in APAC Countries. Established EN/ISO 13485 & ISO 9001 Quality Management System certification, building organizational infrastructure and planning, coaching/mentoring, budget planning, and government relations. She achieved EN/ISO 13485 and ISO 9001 certification for medical device companies, prepared manufacturing facilities for successful competent agency (e.g. FDA) audits and inspections, and attained CE Mark for medical devices, IVDs and drug-device combination products. She is also an advisor, mentor, talent developer, trainer, and change agent in multi-plant manufacturing operations, design controls, risk management, post-market surveillance activities, business continuity planning, and regulatory strategies.

 

Ms Joanna Koh

Joanna worked in the pharmaceutical and medical device (MD) companies as pharmacist and entrepreneur for over 35 years. Currently she is a regulatory consultant/trainer in her personal capacity. She spent 8 years in the Health Sciences Authority of Singapore (HSA) as Regulatory Director, in the MD Branch and Vigilance & Compliance Branch. She retired in 2016 as Senior Regulatory Consultant for both branches. As Director she was involved in the crafting and implementation of the Singapore regulations for MDs. She held the Chair in the Asian Harmonization Working Party Technical Committee (AHWP-TC) (2009-2014) and currently serves as Advisor in the post market workgroup.

Other and regional portfolios included: Co-Chair of the ASEAN Medical Device Working Group ACCSQ; its Technical Committee (MDPWGTC) (2008-2014); Member of the International Medical Device Regulators Forum (IMDRF) UDI Workgroup; Member of GMDN PAG; Member of the Singapore Council of Standards (SCS).

 

Mr Seet Wing Gang

Seet Wing Gang has been in the medical device industry for the over 20 years. Taking on roles in quality and regulatory affairs in manufacturing plants as well as regional offices. Wing Gang had served in the Health Sciences Authority of Singapore for 6 years, the last appointment held was Deputy Director of Evaluation Unit, Medical Device Branch. He was part of the team that developed and implement Singapore’s regulatory framework for medical devices.

Wing Gang had conducted training on regulatory requirements for medical devices for both regulators and industry. He had spoken and conduct training in regional conferences and countries including Indonesia, Thailand, Philippines, Singapore and Vietnam. Wing Gang has a diploma in Biotechnology, Honours Degree in and Masters in Technological Design. He is a certified trainer and has also obtained Singapore Workforce Skills Qualifications (WSQ) Advanced Certificate in Training and Assessment (ACTA).