• Specialized in medical device pre-market submissions with a focus on the APAC and ASEAN markets including Australia, Japan, Malaysia, Singapore, India, Indonesia, and New Zealand• Developed and executed registration strategies for new products and sustaining device modifications for a wide array of medical devices ranging from CPAP masks, sleep diagnostic solutions, home and hospital ventilators, and Software as Medical Devices (SaMDs) • Supported complex establishment and device registration projects which had companywide impact, including legal manufacturer change, Quality Management System (QMS) device scope and facility expansion, manufacturing site shutdown and relocation, field actions, corrections, and recalls• Served as a Regulatory Affairs subject matter expert for the Japanese and Australian markets for the ISO13485 MDSAP audits • Established and standardized localized labeling review process and led intra-company tactical negotiations and peer reviews to ensure all labeling changes proposed from markets do not deviate from the design, safety, effectiveness, and performance of the medical devices • Ensured regulatory transparency to project teams by providing impact assessments on sustaining engineering and labeling changes to aid in inventory planning and avoid disruptions in sales • Authored market-specific registration work instructions in accordance with the local legislations and regulations for medical devices • Trained and mentored newly hired regulatory personnel

• Plan and implement international regulatory strategies for medical device registrations in APAC and ASEAN markets. • Conduct regulatory impact assessments regarding sustaining changes for international markets. • Prepare submission dossiers for new product registrations as well as changes to existing products for the APAC and ASEAN regions. • Collaborate with regional RA leads to learn about changes in local regulations and provide guidance and training to the US teams cross-functionally for change implementations. • Provide prompt support to address registration submission and audit inquiries from the regulatory authorities. • Promptly provide required deliverables to support local RA leads in obtaining and maintaining manufacturing site registrations and renewals. • Work collaboratively with other departments and provide regulatory guidance to ensure smooth product launches in international markets. Knowledgeable about medical device regulatory requirements in Japan, Australia, New Zealand, Malaysia, Indonesia, Taiwan, Hong Kong, India, Sri Lanka, and Pakistan.

• Ensuring product claims and nutrition statements are in compliance with FDA regulations by: - Compiling bulletins regarding updated nutrient definitions/claims and Nutrition Fact Panel requirements via in-depth research of the FDA regulations under 21 CFR- Assisting in the product label reform project to accommodate the changes in Labeling regulations per FDA’s final ruling- Reviewing and approving client product artworks/claims and marketing materials for regulatory compliance- Building product entries in food labeling and nutrition analysis systems to generate sound database for Label Copy generations- Utilizing language skills to communicate with vendors based in China to verify allergen statements and label claims are true as stated

Analytical:- Human ResDNA Quantitative Testing - ELISA (CHO, PER C6, and Biotin-StreptAvidin Binding)- SDS-PAGEDownstream: - Protein purification process development utilizing AKTA systems - Production timeline management- Best Column Packing Practices development & column integrity testing - Viral filtration/filter capacity & integrity testing- UFDF- Drug product stability testingUpstream:- Shake flask & bioreactor cell culture passaging and Harvesting- Cell titer and quality monitoring

• Achieved company goals by forwarding developing drug products to commercial phase in compliant with FDA regulations via:- Preparing and submitting the Drug Master File to the FDA- Reviewing production documentation and summary reports- Compiling risk assessment reports for potential and existing drug manufacturing processes - Organizing cross-functional meetings and maintaining meeting minutes

• Developed teaching strategies to attract prospective students by: - Creating and maintaining teaching program and curriculum - Presenting systematic teaching approaches to parents of prospective students - Communicating with parents regarding students’ English proficiency progress - Teaching English to Mandarin speaking students

- Honored as top sales person in western Canada for 2007- Developed customer data base for sales promotions, and new inventory notifications- Organized and merchandized store products to promote sales