- ISO 13485 QMS operation: operating the Quality Management System (QMS) including records maintenance, document control, supporting internal/external audits, and handling CAPAs- Complaints handling & incident reporting: investigating complaints and incidents, determining root causes in accordance with risk-based approach (ISO 14971), and reporting to the competent authority- Maintaining technical documentation: creation of new technical files and documentation of technical changes; products include class Is, class IIa, and IIb devices- Maintaining regulatory compliance: compliance with UK MDR, EU MDD/MDR- Cross-cultural/functional communication: liaising with international manufacturing sites for QA issues

- Taiwanese medical device regulatory submission strategising- Medical device technical documentation reviewing e.g. biocompatibility report, mechanical test report, clinical evaluation report, etc.- Products included Class IIb devices active devices and implants

* Established the RA department from scratch* Achieved over 400% growth in number of product certifications* Maintained over 50 medical device licenses and 7 manufacturers registrations* Self-sourced public funding for external trainings- Liaised and collaborated with international business partners e.g. Steris, Erbe Elektromedizin GmbH, Apollo Endosurgery, Inc., amg International GmbH, etc., addressing scientific/technical and administrative issues- Conducted regulatory submissions with Taiwanese FDA for class I, II, and III devices - Acquired domain knowledge for each project, including: microscopic instruments, surgical units (active devices), gastroenterological and bronchial implants, and bronchoscopic software

- Intern leader: co-ordinated training rotation, communicating between interns and mentors- Emotional and social intelligence: patient-facing phlebotomy practice- Medical laboratory operation: conducted quality control, operating following SOPs- Data/documents management: patient data collection and documentation, following ISO 15189- Training sectors included: biochemistry, microbiology, pathology, blood bank, medical imaging, and molecular diagnosis sectors