Christina zhou Treasurer - Volunteer at ASQ Silicon Valley Chapter

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Treasurer - Volunteer

ASQ Silicon Valley Chapter

Nov 2022 - Current (3 years 8 months)

- Volunteering as Treasurer for the ASQ Silicon Valley chapter.

Senior Manager, Regulatory Afairs

Thermo Fisher Scientific

Jun 2022 - Aug 2023 (1 year 3 months)

- Manage and oversee the work of different business units for international product registrations. - Accountability for creation and maintenance of global registration requirements. - Advise regulatory affairs teams on creation of local regulatory affairs strategy, change management and implementation, and potential high impact risks. - Build and maintain trusted relationships with regional and business unit regulatory affairs, cross-functional business partners, local regulatory agencies, and national/regional trade associations - Collaboration with internal/external stakeholders on global regulatory activities and product recalls. - Review of supplement labeling to comply with local regulatory requirements. - Maintenance of Certificate of

Regulatory Affairs Manager

Roche

Feb 2021 - Jun 2022 (1 year 5 months)

- Completed, prepared and led the IVDR technical files for multiple system products; completed the tech files for two class A products, AVENIO Edge and Millisect. - Led international registrations including China PTR testing and registrations - Led FDA IVD instrument new product launch - Responsible for RUO sequencing library reagents (hundreds of products), IVD instrument, and software during design and development, and post launch activities

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Senior Project Manager

Intuitive Surgical DHR Quality

Aug 2019 - Feb 2021 (1 year 7 months)

- Responsible for regulatory project timelines and management of China regulatory submissions. - Lead regulatory activities including planning and reviewing of regulatory submissions - Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives - Interact with departments to generate protocols and reports that require for China in-country testing data for registration purposes - Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes - Provide regulatory guidance with regard to preparation, review and approval of English and Chinese labeling and promotional materials as needed - Prepare formal written reports, PowerPoint, Microsoft Project presentati

Senior Manager

Cepheid

Nov 2017 - Aug 2019 (1 year 10 months)

- Responsible for regulatory project timelines and management of global regulatory submissions (Australia, China, Japan, Korea, and other APAC countries). - Managed a group of regulatory specialists (5 full time employees and 2 contract associates) and ensured timely deliverable to meet the registration timelines regulations and guidelines. - Established and reviewed Regulatory Affairs priorities as they relate to department and company goals and objectives - ●Provided proactive regulatory intelligence in areas of a competitive nature and also kept abreast of changes in agency regulations and requirements - Interacted with global regulatory leaders and peers to expedite approval of pending registrations - Interacted with departments to gene

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Senior New Product Quality Engineer

BD Biosciences

Jan 2013 - Jan 2016 (3 years 1 month)

• Supported 2 new IVD products during design and development as new product quality lead. • Supported IVD product 510(k) submission preparation. • Handled projects with diferent subsystems (System V&V, Software, Hardware, Reagents, etc) for risk management documents (System level risk analysis, and subsystemFMEAs) • Participated in supplier qualification and supplier audits. • Assisted in writing, executing and approving process validations. Assisted in reviewing and approving system verification protocols and reports. • Supported in Human Factor and Usability discussions, including drafting the plan, task analysis, andreport. • Provided trainings to promote Quality knowledge (DFM, Risk Management, Design Control, Human Factors & Usab

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BioProcess Engineer II

BD Biosciences

Jan 2010 - Jan 2013 (3 years 1 month)

• Core Team member for Fusion Protein Project; support Fusion Protein project as a reagent operations representative. • Core Team member for New Dye Development, support all new dye development as a reagent operations representative. • Conducted validation and verification for diferent processes and products. • Actively participated in team meeting with cross functional departments, Marketing, Program Management, R&D, Quality and Regulatory. • Drafted Viability Report and Reagent Operations Plan for new products. • Financial acumen; capable of planning and oversight of project budgets and product valuations; understanding of portfolio management concepts • Created BOMs and Routings for new products. Worked with planners to initiate pr

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Reagent Development Associate II, Application Feasibility Development

BD Biosciences

Apr 2008 - Jan 2010 (1 year 10 months)

• Conducted QC test method engineering study. • Conducted feasibility study, formulation, format, preliminary stability, feasibility lot build, research study, and Protocol Standardization. • Conducted development study, select formulation, DOE on key ingredient, development lot build, stability, research study, and process development. • Verified development lot performance, stability, and process development. • Validated new processes with Operation Team and new product with System ValidationTeam. • Assisted in Capture Bead conjugation verification and PE Detector verification. • Operated CANTO II HTS to acquire samples.

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Senior Regulatory Afairs Specialist

BD Biosciences

Apr 2008 - Oct 2017 (9 years 7 months)

• Supported international product registrations, specializing in APAC countries such as China, Japan, Korea, India, Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam, etc. • 5+ new product registrations; 3 changes; 10+ extensions; Japan: 2+ new medical device filing; Korea: 5+ new medical device filing; 5+ changes; India: 200+ new product registration and renewals; Indonesia: 30+ new product registrations and renewals. Malaysia: 3+ new medical device filing; Singapore: 5+ new medical device filing; Vietnam: Supporting Decree 36 new regulations, and import permits 100+ products • Participated in NMPA (China FDA) overseas onsite audit as a translator to the auditors. • Supporting manufacturing site change/ product transfer act

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Research Associate II

StemCells Inc

Sep 2005 - Mar 2008 (2 years 7 months)

• passaged, frozen & banked cultures of human neural stem cells. • stem cell selection by using MACS Microbeads. • and analyzed spinal cord injured mouse peripheral blood samples with various cell surfacemakers. • adult human stem cells for transplantation studies, and performs neonatal transplant surgeries. • performing cryo-sectioning of mice brains, tissue section staining and slide mounting. • FACS pheno-typing analysis for clinical department and various antibody analysis forR&D. • cell sorting by using FACS Vantage to separate cells by sizes and cellmarkers.

Christina zhou

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