Experience

Assembly Works

• Singapore
• Accounting
• 1 - 100 Employee

• Management

  • May 2022 - Present



Medtronic

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• QRA Lead

  • Feb 2021 - Apr 2022

• RA Supervisor

  • Aug 2019 - Jan 2021



Teleflex

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• senior ra specialist, team lead

  • Mar 2018 - Jul 2019

• Regulatory Affairs Specialist

  • Sep 2015 - Mar 2018

  Front-Desk Registration Regulatory Affairs Role• Submission of registration, change notification dossier and post-market surveillance to regulatory authorities in Singapore and Malaysia• Maintenance of regulatory licence and records• Coordinating regulatory submissions by distributors in the region (Thailand, Myanmar, Philippines, Indonesia, Vietnam, Pakistan)Business Unit Regulatory Affairs Role• Regulatory strategy support for change management and product development• Sustainability regulatory affairs work, maintenance of technical files, regulatory intelligence and assessment of new standards requirements• Reviews of technical documents, including Engineering Change Orders, Document Change Orders, Validation Protocol and Reports• Drafting of instructions for use and coordinating all stakeholders for the release for commercial use as well as supporting the release of other documents by the RA team• Represent RA for multi-functional team meetings and project teams• Coordinating of final deliverable in key projects to ensure project is closed in a fully-compliant manner• Operates in a ISO13485 compliant QMS



Health Sciences Authority

• Public Safety
• 500 - 600 Employee

• Regulatory Specialist

  • May 2013 - Sep 2015

  • Evaluation of product registration applications and related matters. • Guide the MDB TradeNet team with the responsibility for liaising, supporting and advising industry stakeholders with health product shipments that are stuck at the Singapore Customs • Work with other branches and controlling agencies to derive a clearance/rejection strategy for the shipments stuck at Singapore Customs. • Responding to general enquiries regarding the Health Product Act and Medical Device Regulations. • Formulating regulatory policy and decision. • In-charge of several projects to improve/correct work processes and policies within the organization.



SysteMED Pte Ltd

• Project Executive

  • Jan 2012 - Jun 2012

  • Did market research and due diligence on various medical device fields. • Individually managed a project, work included idea generation, product design, prototyping, grant application, budgeting, market research and business planning. • Help in analyzing medical devices and ideas generation for new projects. • Did market research and due diligence on various medical device fields. • Individually managed a project, work included idea generation, product design, prototyping, grant application, budgeting, market research and business planning. • Help in analyzing medical devices and ideas generation for new projects.