Pua Weicheng
Summary
Adept in medical device product registration and leading quality management initiatives, I have significantly contributed to the regulatory success at Canon Medical Systems Asia. My expertise encompasses ISO standards compliance and conducting medical device audits, paired with a talent for fostering cross-divisional collaboration to achieve certification milestones and enhance operational excellence.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Assistant Manager, Regulatory Affairs and IMS
Canon Medical Systems Asia
01.2025 - Current
- Successfully registered multiple Class C medical devices with HSA Singapore directly and Thai FDA by timely management of distributor submission, while working in conjunction with the product owner to ensure all registration projects are updated to headquarters in a timely manner.
- Independently coordinated the successful completion of SS620, ISO 9001, ISO 45001, and ISO 14001 certification audits with external certification in the first three months of joining by actively working with cross-division stakeholders.
- Facilitated internal audits in compliance with SS620, ISO 9001, ISO 45001, and ISO 14001 to ensure timely reporting of findings.
- Contribute in the capacity of subject matter expert, providing critical inputs for the implementation of Oracle ERP systems so that processes are aligned with ISO-based processes.
Medical Device Lead Auditor
SGS International Certification Services
10.2021 - Current
- Independently planned, conduct and report medical device audits in accordance to the requirements of ISO 13485:2016, SS620:2016 the requirements of HSA pertaining to medical devices for medical device companies
- Independently planned, conduct and report audits in accordance to the requirements of ISO 9001:2015 for organization pursuing quality excellence
- Consideration of ISO 14971:2019 and its application in the course of audit
Senior Regulatory Affairs and Quality Engineer
AWAK Technologies
04.2020 - 10.2021
- Developing regulatory strategy for ongoing projects by liaising with HSA and internal team members
- Upkeep the existing ISO 13485:2016 quality management system to ensure compliance from all team members
- Serves as Internal auditor for ISO 13485:2016 for and provide training to staff on quality related topics
Regulatory Affairs and Quality Assurance Manager
Opto-Pharm
07.2019 - 04.2020
- Coordinate testing with both external vendors and internal teams to generate documentation to fulfil regulatory requirements for product registration for countries including but not limited to Singapore, Europe, China, Taiwan and USA
- Supervise a team of quality and regulatory executives in raw material and finished product approval on a daily basis
- Translate English documentation to Chinese for regulatory submission to China market
Chemistry Teacher
Ministry of Education
01.2014 - 06.2019
- Taught Chemistry for at both Junior college and Secondary school levels
- Provided mentoring and pastoral guidance for youth age ranging from 13 years to 18 years
Regulatory Affairs and Quality Assurance Specialist
Smith and Nephew
06.2013 - 12.2013
- Secured GDPMDS certification for the company as the lead internal auditor and handling of external audits by certified bodies
- Ensured that field safety actions such as product recall or advisory are executed professionally and in compliance with Singapore Health Sciences Authority (HSA) requirements by serving as the point contact of HSA with the company
- Successfully applied for a license to import and supply Medical device for clinical trial use under Import of Clinical trial Materials (CTM) for the use for an unregistered medical device in clinical trial
- Enforces regulatory compliance of Company Quality Management System requirements in South East Asia region, with specialization in post marketing surveillance system
- Execute training programs across South East Asia Region to meet the needs for employees in quality and regulatory requirements, customer complaints and safety incident reports
- Update regulatory changes in Singapore to upper management to facilitate regulatory strategy planning
- Review Marketing materials to ensure regulatory compliance
Regulatory Affairs and Quality Assurance Specialist
St Jude Medical
04.2011 - 06.2013
- Secured GDPMDS certification for the company as the lead internal auditor and handling of external audits by certified bodies
- Ensured that field safety actions such as product recall or advisory are executed professionally and in compliance with Singapore Health Sciences Authority (HSA) requirements by serving as the point contact of HSA with the company
- Successfully applied for a license to import and supply Medical device for clinical trial use under Import of Clinical trial Materials (CTM) for the use for an unregistered medical device in clinical trial
- Enforces regulatory compliance of Company Quality Management System requirements in South East Asia region, with specialization in post marketing surveillance system
- Execute training programs across South East Asia Region to meet the needs for employees in quality and regulatory requirements, customer complaints and safety incident reports
- Update regulatory changes in Singapore to upper management to facilitate regulatory strategy planning
- Review Marketing materials to ensure regulatory compliance
Contract Regulatory Affairs Associate
3M Technologies
08.2010 - 04.2011
- Plan and conduct Internal Audits for Medical device Business Entities based on Good Distribution Practice for Medical Device (GDPMDS) as required by Health Science Authority of Singapore
- Carried out Product registration and handled product recall successfully in accordance to Singapore Health Science Authority (HSA) regulations
- Successfully handled external audits by certification bodies in securing the GDPMDS certification crucial for the business
- Conducted Management Review for management as required by the GDPMDS quality management system
Quality Control Engineer
Hoya Medical Singapore
02.2008 - 07.2010
- Leader of a three-person team that completed a major equipment validation project directly affecting product expiry period, three weeks ahead of given timeline
- Implemented statistical process control in processes by conducting training courses for engineering personnel on statistics applications
- Trained in Statistical Process control from Productivity and Standards Board (PSB) academy
- Independently developed software validation for Minitab software in response to FDA request with reference to Title 21 CFR Part 11
- Develop testing methods with Utilize Headspace-Gas chromatography (HS-GC), High Performance Liquid Chromatography (HPLC), Fourier Transform Infrared (FTIR) and UV Spectroscopy to ensure product’s quality meets the required standard
Education
ISO 13485:2016 Medical Devices Lead Auditor Training Course. ISO 13485 Cert. No: 64090562/155274141 - ISO 13485:2016 Medical Devices Lead Auditor
SGS International Certification
Singapore09-2021
Bachelor of Science - Chemistry
National University of Singapore (NUS)
Singapore06.2007
Skills
- Medical Device Product Registration
- Field safety corrective actions
- ISO standards
- Quality management
- Medical device audits
Accomplishments
- Led and coordinated an immediate response with international regulatory affiliates in UK to prevent the deportation of a quantity of medical device of substantial value, winning the best employee award in Smith and Nephew in the process.
- Best Poster Award for Honours Thesis 2007 by German Institute of Technology. “Functionalization and Self-assembly of Segmented Metal Nanowires”
Languages
English
First Language
Chinese (Mandarin)
Intermediate (B1)
B1
Indonesian
Beginner
A1
Certification
ISO 13485:2016 Medical Devices Lead Auditor Training Course
ISO 13485 cert. no: 64090562/155274141
ISO 9001:2015 - Quality Management Systems Auditor/Lead Auditor Training Course
ISO 9001 cert. no :64078140/155003776
References
References available upon request.
Timeline
Assistant Manager, Regulatory Affairs and IMS
Canon Medical Systems Asia
01.2025 - Current
Medical Device Lead Auditor
SGS International Certification Services
10.2021 - Current
Senior Regulatory Affairs and Quality Engineer
AWAK Technologies
04.2020 - 10.2021
Regulatory Affairs and Quality Assurance Manager
Opto-Pharm
07.2019 - 04.2020
Chemistry Teacher
Ministry of Education
01.2014 - 06.2019
Regulatory Affairs and Quality Assurance Specialist
Smith and Nephew
06.2013 - 12.2013
Regulatory Affairs and Quality Assurance Specialist
St Jude Medical
04.2011 - 06.2013
Contract Regulatory Affairs Associate
3M Technologies
08.2010 - 04.2011
Quality Control Engineer
Hoya Medical Singapore
02.2008 - 07.2010
ISO 13485:2016 Medical Devices Lead Auditor Training Course
ISO 13485 cert. no: 64090562/155274141
ISO 9001:2015 - Quality Management Systems Auditor/Lead Auditor Training Course
ISO 9001 cert. no :64078140/155003776
ISO 13485:2016 Medical Devices Lead Auditor Training Course. ISO 13485 Cert. No: 64090562/155274141 - ISO 13485:2016 Medical Devices Lead Auditor
SGS International Certification
Bachelor of Science - Chemistry
National University of Singapore (NUS)
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