KAREN Hui
San Ramon,CA
Summary
Self-motivated, adaptable professional with over 10 years of experience in product compliance. Proactively project manage, execute necessary tasks, and meet deadlines for multiple projects with minimal oversight. Strive to collaborate with internal and external customers by communicating effectively, identifying any problems and seeking out solutions to efficiently meet compliance and company goals.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Stay-at-home Parent/ Household CEO
02.2025 - Current
- Raised child and managed household
- Transferable Skills: Problem solving, adaptable to unfamiliar environments and unexpected chall, detail-oriented
New Home Sales Assistant
JWilliams Staffing
06.2024 - 01.2025
- Assist on-site sales team with presenting homes to prospective buyers
- Establish rapport with prospective buyers to determine their housing needs
- Provide excellent customer service to real estate sales agents and prospective buyers
Senior End-To-End Compliance Engineer
Logitech
San Jose, CA
07.2022 - 04.2024
- Project managed and completed compliance testing and certification for announced and confidential new product introductions (NPIs), as well as products in sustaining
- Subject matter expert on safety, EMC/ RF, and international approvals
- Responsibilities included creating labeling guides, completing 3rd party testing and reports according to test plan, managing samples and submitting documentation for international approvals, applying design/ change control throughout product life cycle, interfacing with component vendors to obtain technical information, providing weekly updates to project teams, generating EU/UK declarations of conformity (DoCs), and updating budgets for projects
- Cooperated with internal technical safety/RF/EMC reviewers, environmental compliance, and legal to ensure products are compliant to all relevant regulations and standards
Field Sales Executive
TUV Rheinland
Pleasanton, CA
09.2019 - 06.2022
- Recommended end-to-end compliance strategies on multiple product types including consumer and enterprise, automotive, and lab and measurement equipment
- Provided internal and external guidance based on extensive knowledge in Safety, EMC/ RF, hazardous substances/ chemistry, wireless interoperability, and market access services
- Increased revenue and new client count through client referrals, leads and marketing events
Senior Regulatory Affairs Specialist
Illumina, Inc.
Hayward, CA
07.2016 - 09.2019
- Met launch dates for 6 major NPIs by executing all testing and certification
- Maintained compliance for 10+ legacy instruments with life cycle management teams
- Authored compliance strategies, labeling, protocols and verification reports to help demonstrate product’s compliance to domestic and international standards and regulations
- Compiled CE mark technical files and generated DoCs
- Applied risk assessment, design/change control, and product development processes
- Liaised with and third party agencies to complete compliance testing, registrations, and audits
- Corroborated with third party suppliers on component and OEM equipment compliance
- Represented compliance as a core stakeholder in creating global trade system to manage market access of regulated devices, components and accessory equipment
Education
Bachelor of Science - Biological Sciences
University of California, Davis
06-2008
Bachelor of Arts - Communications
University of California, Davis
06-2008
Skills
- MS Office
- Languages: Chinese (Cantonese, Mandarin)
- Systems: SAP, Ariba, Workday, Quickbase, Salesforce, Microsoft teams, Skype, Webex, Slack, Gmail and Google meet
Accomplishments
- Certificate of Recognition 04/2019Illumina, Inc.Created and managed hardware compliance verification for global trade and market access
- NSF Medical Lead Auditor Course 01/2019Illumina, Inc.Audit requirements according to ISO 13485 and MDSAP requirements
- Certificate of Recognition 09/2016Illumina, Inc.Outstanding contributions on the NovaSeq program in negotiating in-country RFID testing requirements, significantly reducing the required scope and over $1 million in cost savings
Certification
Regulatory Affairs and Medical Devices Dual Certification 2019
Languages
Chinese (Cantonese)
Native or Bilingual
Chinese (Mandarin)
Professional Working
Timeline
Stay-at-home Parent/ Household CEO
02.2025 - Current
New Home Sales Assistant
JWilliams Staffing
06.2024 - 01.2025
Senior End-To-End Compliance Engineer
Logitech
07.2022 - 04.2024
Field Sales Executive
TUV Rheinland
09.2019 - 06.2022
Senior Regulatory Affairs Specialist
Illumina, Inc.
07.2016 - 09.2019
Bachelor of Arts - Communications
University of California, Davis
Bachelor of Science - Biological Sciences
University of California, Davis