Echo Yu, Ms, Rac (Global), Exin® Dpo (Gdpr) Email & Phone Number

Markham, On, Ca

- Lead regulatory submissions including 510(k) premarket notifications and Q-subs for US FDA. - Design and execute product clinical validation studies in United States. - Formulated comprehensive regulatory and clinical strategies for all submissions in China, encompassing regulatory pathways and clinical evaluation plans. Accurately estimated registration timelines and associated costs. - Cultivated robust relationships with key stakeholders in China's medical device landscape, including regulatory authorities, reviewers, technical service providers, consulting firms, CROs, custom clearance agents, and legal service providers. - Established and led a high-performing Regulatory Affairs team based in China, ensuring the effective execution of registration plans and compliance activities.Devised a robust reimbursement strategy to facilitate widespread adoption of medical devices, taking into account the financial accessibility for end-users.

Shanghai, Shanghai, Cn

Determine and document appropriate regulatory strategy for proposed new AI/ML based SaMD products. Support design control activities.• Lead regulatory submissions including NMPA Class III, EU MDR and 510(k) premarket notifications Q-subs for US FDA.• Design and execute product clinical validation studies in United States.• Lead new product introduction projects that support China NMPA submissions

Chicago, Il, Us

-Develop regulatory strategy in support of AI/ML-Based device clearances globally, experienced in US FDA de novo, 510(k), Canadian Licensing, EU Technical File, Australia TGA and CFDA registration.-Acts as liaison for UL/CSA/INTERTEK/SGS/TUV inspection/ follow-up activities.-Geographic Responsibility – US, Canada, EU, Australia, Brazil, China, Japan, Russia, Middle East, South and Central America, Eastern Europe and Asia.-Key contributor to Traditional 510k clearance K173475, K182290, K192455.

Framingham, Ma, Us

- Prepare and maintain annual reports and renewals, such as CFDA re-registration, US FDA Annual Establishment renewal, US FDA Annual Laser Reports, EU Medical Device annual review of post-market surveillance and clinical data.- Author to DEN170019. Key contributor to EU IVDD regulatory approval for API 3200MD, 4500MD and QTRAP® LC/MS/MS systems

Cincinnati, Ohio, Us

- Develop regulatory strategies to secure rapid approvals with optimum labelling with Health Canada for OTC Drug, Natural Health Products, Cosmetic Product and Medical Devices.- Obtained Health Canada approval of Class II device- Provide global regulatory impact assessments to US, EU, CA, and APAC

Master’S Degree, Biology

Bachelor Of Science - Hbasc, Biomedical/Medical Engineering

Pharmaceutical Regulatory Affairs And Quality Operations