Jaymie Wong-See

•Prepared of regulatory applications for medical device market clearance (i.e. FDA and EU (MDD/MDR)) for medical devices specifically, in the Neuromodulation sector.

•Developed and communicated regulatory strategies for new product introduction and other projects.
•Assisted in regulation changes of new and current products.

•Reviewed Marketing Materials with an in-depth understanding of TGA and MTAA Advertising Codes.
•Provided regulatory guidance to all company departments, from design development to post market surveillance
•Assisted in regulatory actions such as incident reporting, device vigilance, device registration, and other pre- and post-market responsibilities as per relevant regulations, including those of the EU, Australia and USA.

•Adhered and promoted compliance to local and international regulations and QMS.

•Involved in CAPA activities, to ensure that issues are addressed properly and prevented from recurring

•Established and maintained a good working relationship with regional and divisional RA peers to gain positive & timely support for document preparation, submission and approval

•Developed training materials for new hires, facilitating knowledge transfer and enhancing overall team competency in regulatory affairs.

•Participated in audits conducted by external agencies, demonstrating professionalism and expertise in addressing any findings or recommendations presented during the process.

•Conducted risk assessments to identify potential areas of non-compliance, implementing corrective actions as needed.

•Preparation of regulatory applications for medical device market clearance (i.e. 510k and CE marking) for orthopaedic implants and their accessories, including joint replacement prostheses, fracture and soft-tissue fixation devices as well as their related surgical instrumentation
•Preparation of technical reports and technical files
•Development and execution of product verification testing in accordance with recognized national and international standards for medical devices (i.e. ISO, ASTM)
•Clinical evaluation of medical devices via literature review and clinical data analysis
•Provide regulatory guidance to all company departments, from design development to post market surveillance
•Assist in regulatory actions such as incident reporting, device vigilance, device registration, and other pre- and post-market responsibilities as per relevant regulations, including those of the EU, Australia and USA.