Roxanne Kong Email & Phone Number

Singapore

Singapore

Biomed plus is a platform that provides you the latest biomedical news, workshops, talks and job openings for both alumni and undergraduates.https://www.facebook.com/biomedplus/ • Responsible for curating and disseminating Bioengineering news, events and job openings daily on our Facebook page• Organised and conducted talks for graduating Polytechnic Biomedical students to increase awareness of future possibilities in the Biomedical sector

Singapore, Singapore

• Assessed and documented change assessments for responsible countries within change management electronic system• Executed and tracked regulatory submissions to ensure regulatory conformance and alignment with global regulatory strategy• Maximised submission efficiency by collating possible regulatory filings in one submission without delaying regulatory timeline• Prepared regulatory dossiers for submission to differentgovernmental agencies to facilitate regulatory submissions… Show more • Assessed and documented change assessments for responsible countries within change management electronic system• Executed and tracked regulatory submissions to ensure regulatory conformance and alignment with global regulatory strategy• Maximised submission efficiency by collating possible regulatory filings in one submission without delaying regulatory timeline• Prepared regulatory dossiers for submission to differentgovernmental agencies to facilitate regulatory submissions and maintain product registration approvals• Liaised with Health Authorities to answer questions for post-approval changes/ new product registrations• Represented Regulatory Affairs during cross-functional discussions to minimise write-offs/ impact to affected products and markets due to regulatory changes or production causes• Ensured constant flow of information from local to area/global teams to promote awareness of new regulations/ submission progress Show less

Singapore

Performed Engineering Change Orders to implement changes and streamline Manufacturing/Operational processesPerformed sourcing of supplier and technologyDetermined QMS requirements for product revivalPerformed responsibilities related to Inventory, IT and Purchasing management

Singapore

Brief overview: Engineering work to drive and deliver labelling changes across final packaging materials by collaborating with cross-functional stakeholders, whilst ensuring compliance with regional/global regulatory standards.• Creation/revision of new/existing packaging materials required in final products (e.g. Labels, IFUs, Patient ID cards, Outer boxes, etc.) to meet ISO and regulatory requirements to upkeep quality standards and regulatory compliance• Liaised with global… Show more Brief overview: Engineering work to drive and deliver labelling changes across final packaging materials by collaborating with cross-functional stakeholders, whilst ensuring compliance with regional/global regulatory standards.• Creation/revision of new/existing packaging materials required in final products (e.g. Labels, IFUs, Patient ID cards, Outer boxes, etc.) to meet ISO and regulatory requirements to upkeep quality standards and regulatory compliance• Liaised with global Regulatory Affairs, cross-functional and project stakeholders and vendors to ensure timely delivery of compliant packaging products• Streamlined and conducted quality checks and documentations without forgoing quality assurance to improve efficiency and quality standards for packaging products to upkeep quality of products• Led and co-ordinated change for automation in Operations for streamlined and efficient processes • Provided engineering support (qualification and implementation) for business continuity through end-of-life component management in collaboration with cross-functional stakeholders Show less

Singapore

Brief overview: Engineering work to drive and deliver labelling changes across final packaging materials (with a primary focus on quality) by collaborating with cross-functional stakeholders, whilst ensuring compliance with regional/global regulatory standards.• Creation/revision of new/existing packaging materials required in final products (e.g. Labels, IFUs, Patient ID cards, Outer boxes, etc.) to meet ISO and regulatory requirements to upkeep quality standards and regulatory… Show more Brief overview: Engineering work to drive and deliver labelling changes across final packaging materials (with a primary focus on quality) by collaborating with cross-functional stakeholders, whilst ensuring compliance with regional/global regulatory standards.• Creation/revision of new/existing packaging materials required in final products (e.g. Labels, IFUs, Patient ID cards, Outer boxes, etc.) to meet ISO and regulatory requirements to upkeep quality standards and regulatory compliance• Liaised with global Regulatory Affairs, cross-functional and project stakeholders and vendors to ensure timely delivery of compliant packaging products• Streamlined and conducted quality checks and documentations without forgoing quality assurance to improve efficiency and quality standards for packaging products to upkeep quality of products• Led and co-ordinated change for automation in Operations for streamlined and efficient processes • Managed day-to-day Production Operation checks to ensure end product quality• Provided engineering support (qualification and implementation) for business continuity through end-of-life component management in collaboration with cross-functional stakeholders Show less

455A, Jalan Ahmad Ibrahim Singapore 639939

Brief overview: Engineering work for the department for yield improvement, cost reduction and end of life issue. Provision of technical support for production regarding troubleshooting of daily production issues related to Packaging & Sterilisation• Stabilisation of production quality and yield improvement activities related to packaging and sterilisation processes• Ensured all production processes to be conducted based on business risk perspective for sustained… Show more Brief overview: Engineering work for the department for yield improvement, cost reduction and end of life issue. Provision of technical support for production regarding troubleshooting of daily production issues related to Packaging & Sterilisation• Stabilisation of production quality and yield improvement activities related to packaging and sterilisation processes• Ensured all production processes to be conducted based on business risk perspective for sustained engineering• Troubleshooting of daily production issues related to sterilisation and packaging processes, as well as implementation of preventive measures, countermeasures and investigation of problem points to ensure normal / improve production yield• Qualified and prepared reports related to installation of new processes, equipment, materials and new products to improve production yield• Ensured sustainability of production through end-of-life component management• Edited/ revised/ created artworks of packaging materials like Instructions for Use and outer box labels to comply with global/ regional regulatory standards for sale of products into market• Led and managed changes by coordinating and managing the changes and documentation processes Show less

Enrolled in NUS Undergraduate Research Opportunity Programme (UROP) to develop a DNA methyltransferase assay for early cancer detection.

Singapore

Rotation among the different units in stem cell banking laboratoryHands-on processing of testing samplesPerform Quality assurance and International accreditation checksUnderstood Standard Operation Procedure (SOP) of processing cord blood and lining to create questionnaires or test questions

Singapore

Mails - assisted to collect, sort and distribute in-coming or out-going mails, faxes and circulars Data collation - assisted in data collation for training related matters, such as attendances collation, training evaluation forms data entry, outcomes data trackingProvided admin and logistic support for training events

Bachelor Of Engineering (B.Eng.) (Hons), Biomedical/Medical Engineering

Activities and Societies: Windsurfing BME Prom 2017 Planning Committee - Programme - Coordinated and streamlined activities to be carried.

Education record

Activities and Societies: Sailing & Symphonic Band Sailing: Female Captain (2011 – 2012) Annual Sailing Camp 2012 - Chairperson CCA.

Education record

Activities and Societies: Concert Band & Student Council/Student Leaders'​ Board Alumnus: Mayflower Alumni Executive Committee member.