Yuen Wai Leng
Singapore
Summary
Seasoned Regulatory Affairs Officer with 10 years in developing effective processes and executing regulatory affairs initiatives for medical device industry. Improved processes and assisted product development in meeting regulatory requirements. Maintained and followed up on records of regulatory information and submissions.
Overview
27
27
years of professional experience
Work History
Quality Assurance & Regulatory Affairs Manager, SEA & South Asia
Evident Scientific Singapore Pte Ltd
04.2022
- Ensure processes needed for the quality management system are established, implemented and maintained
- Lead the internal audit team in annual internal audit exercise and main contact person for external certification body
- Initiate and lead Quality Management Review, in the capacity of Management Representative for the QMS
- Conduct quality audits for qualification of critical 3rd party vendors / suppliers
- CAR (Corrective Actions Request) management, ensuring corrective actions are followed through and implemented effectively
- Interpret and analyze quality objectives against set targets, report to top management on the performance and propose actions to drive improvement, if any
- Ensure post-market vigilance actions (Field Safety Corrective Actions, Recall) execution in accordance to manufacturer’s instruction and local regulatory compliance requirements
- Work with stakeholders to manage customer complaints, escalate critical issues relating to quality defects and adverse events to manufacturer for investigation
- Ensure full product compliance in accordance with regulatory agencies’ requirements across SEA and South Asia
- Provide advice and guidance to business units regarding regulatory requirements
- Work with business units, including distributors on regulatory strategies to ensure product market launch align with planned date
- Ensure processes are in place which comprehensively governs product registrations, authority reporting in relation to field safety corrective actions, recall and adverse events
- Initiate meeting with regulators to resolve registration and licensing challenges
- Conduct training and education on QA/RA related topics, creating awareness and enhancing a quality and regulatory mindset among all staff
- Manage and lead the QA/RA team with particular focus on supporting and developing performance
- Quarterly reporting on QARA activities to APAC QARA Head
- Member of Risk Assessment Team for Workplace Safety Management System under the Workplace Safety & Health regulation.
Senior Regulatory Affairs & Quality Assurance Specialist
Arthrex Singapore Pte Ltd
01.2020 - 03.2022
- Documentation version control and records retention to ensure compliance to established SS 620 GDPMDS Management System
- Conduct annual internal audit and support external 3rd party audit assessment
- Work with distributors to execute Field Safety Corrective Actions, including recalls and local authority reporting
- Support distributors in adverse event investigation and local authority reporting
- Awareness training on SS 620 GDPMD Management System to new hires
- Manage all regulatory affairs activities for SEA, Hong Kong and Taiwan markets, ensuring the process for registering and obtaining regulatory approvals for new/extension and change products with sufficient lead time for market introduction
- Ensure compliance to other regulatory bodies, eg NEA and IMDA in Singapore.
Regional Regulatory Affairs Manager
Carl Zeiss Pte Ltd
01.2014 - 01.2020
- Established processes for the implementation and maintenance of GDPMDS Management System in Singapore and Malaysia
- Align local processes with global to ensure compliance to global ISO 9001 certification
- Annual internal audits across SEA offices, which include GDPMD internal audit in Singapore and Malaysia, ISO 9001 internal audit in Singapore, Malaysia and Thailand, ISO 17025 internal audit in Singapore
- Support 3rd-party QMS audit assessment
- Work with business units to manage customer complaints, escalate critical issues in relation to quality, adverse events to manufacturer for investigation
- CAR (Corrective Action Request) management
- Assist Management Representative in annual Quality Management Review with top management
- Awareness training on ISO 9001 and GDPMD Management System to new hires
- Risk Management Leader for BizSafe Level 3 Management System under the Workplace Safety & Health regulation
- Work with business units, including distributors on regulatory strategies to ensure product market launch align with planned date
- Dossier compilation for medical device registration and change notification submission, ensuring compliance to local regulatory requirements, across SEA (Singapore, Malaysia, Thailand, Vietnam, Indonesia, Philippines, Myanmar)
- Renewal of product registrations and dealers’ licences
- Execution of post-market vigilance actions (Field Corrective Safety Actions, Recall) in accordance to manufacturer’s instruction and local regulatory compliance requirements
- Field Safety Corrective Action, Recall and Adverse Event reporting in accordance to local regulatory Authority requirements
- Ensure compliance to other regulatory bodies, eg NEA and IMDA in Singapore, SIRIM in Malaysia.
Sales Administration Manager cum Regulatory Affairs Officer/Internal Auditor
Carl Zeiss Pte Ltd
01.2008 - 12.2013
- Work with Business Development Managers on promotion and advertisement initiatives across South East Asia operations, ensuring regulatory compliance in the local context
- Event management for local and overseas trade exhibitions, workshops, product launches and product trainings.
Regional Marketing Coordinator
Carl Zeiss Pte Ltd
01.2003 - 12.2007
- Marketing, sales and administrative support for Singapore and SEA offices (Malaysia, Thailand, Vietnam, Philippines & Indonesia)
- Event management for local and overseas trade exhibitions, workshops, product launches and product trainings.
Executive Secretary to Directors
Kosma Holdings Pte Ltd
07.2002 - 11.2002
- Provide full secretarial and administrative support to the Directors
- Draft reports and correspondences
- Maintain up-to-date filing of documents.
Corporate & Marketing Communications Executive
Ascendas Pte Ltd
06.2000 - 06.2002
- Production of marketing collaterals
- Maintained and update information of corporate presentation slides
- Local and overseas event management
- Provide marketing support to overseas offices.
Personal Assistant to Vice President
CEH Group of Companies
03.1995 - 03.2000
- Provide full secretarial and administrative support to the Vice President
- Schedule meetings and arrange business travels
- Draft reports and correspondences
- Co-ordination and liaison for trade exhibitions.
Education
Singapore Institute of Management
National University of Singapore
Skills
- Regulatory Submissions
- Regulatory Strategy
- Labeling Compliance
- Clinical Trial Oversight
- Medical Device Regulations
- Regulatory Intelligence
Personalparticulars
Yuen Wai Leng, Female, Singaporean, Single, Chinese / Cantonese, Blk 118A Jalan Membina, Singapore, 161118, 9783 2589, ywleng@hotmail.com
Training
- 03/05/04, ISO 9001:2000 Internal Auditor
- 01/16/09, Good Distribution Practice for Medical Devices Singapore
- 03/11/09 - 03/12/09, ISO 9001:2008 Internal Auditor
- 08/13/12 - 08/17/12, ISO 9001:2008 Lead Auditor
- 03/17/14 - 03/18/14, Apply Root Cause Analysis
- 05/14/14, ISO 17025:2005 Internal Auditor
- 05/29/14, Good Distribution Practice for Medical Devices Malaysia
- 07/07/14 - 07/08/14, Develop a Risk Management Plan for BizSafe Level 3
- 02/03/16 - 02/04/16, ISO 9001:2015 Internal Auditor
- 09/16/16, Standards Adoption Workshop on Fundamentals of ISO 13485 and Transition to ISO 13485:2016
- 11/07/16 - 11/09/16, Implement Lean Six Sigma
- 04/17/17 - 04/19/17, Business Process Re-engineering
- 08/14/17 - 08/17/17, Manage Hazardous Substance
- 11/16/17, Standards Adoption Workshop on SS620:2016 GDPMD Requirements
- 07/30/18, Navigating ISO/IEC 17025:2017
- 06/28/19, Internal Auditing to ISO/IEC 17025:2017
- 11/27/23 - 11/28/23, 8D Methodology Problem Solving & Improvement Tools
Timeline
Quality Assurance & Regulatory Affairs Manager, SEA & South Asia
Evident Scientific Singapore Pte Ltd
04.2022
Senior Regulatory Affairs & Quality Assurance Specialist
Arthrex Singapore Pte Ltd
01.2020 - 03.2022
Regional Regulatory Affairs Manager
Carl Zeiss Pte Ltd
01.2014 - 01.2020
Sales Administration Manager cum Regulatory Affairs Officer/Internal Auditor
Carl Zeiss Pte Ltd
01.2008 - 12.2013
Regional Marketing Coordinator
Carl Zeiss Pte Ltd
01.2003 - 12.2007
Executive Secretary to Directors
Kosma Holdings Pte Ltd
07.2002 - 11.2002
Corporate & Marketing Communications Executive
Ascendas Pte Ltd
06.2000 - 06.2002
Personal Assistant to Vice President
CEH Group of Companies
03.1995 - 03.2000
Singapore Institute of Management
National University of Singapore
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