Experience

Blackrock Neurotech

• United States
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Regulatory Affairs Specialist

  • May 2022 - Present



Keya Medical

• United States
• Medical Device
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Jul 2020 - May 2022

  - Prepare and review regulatory submissions to obtain and maintain FDA regulatory approvals of software as medical device (SAMD) products, including 510(k) and related submissions- Review software product validation, clinical protocols, and reports- Collaborate with Engineering, R&D Development, Marketing, Clinical, and other departments to ensure regulatory requirements are met in the markets where devices are distributed- Support quality compliance with 21 CFR and ISO 13485- Facilitate software product development by providing regulatory pathway analysis and data compliance requirements- Review product labeling, user training materials, promotional and advertising material for compliance to regulations



University of Southern California

• United States
• Medical Practices
• 1 - 100 Employee

• Regulatory Affairs Consultant

  • Jan 2019 - Jul 2020

  Provide regulatory compliance consulting services to USC research faculties and local start-up companies with products across pharmaceuticals, biologics, medical devices, and dietary supplements - Submission Writing: prepare, develop and write technical reports for FDA submissions including IND, pre-IND meetings, Orphan Drug designations, and 510(k)- Data Analysis: Research and conduct data analysis on clinical trial data to develop regulatory strategies- SOP Development:Draft SOPs and work instructions to support regulatory compliance - International / Chinese Regulations: Specify the regulatory provisions in China by compiling routine regulatory information from Chinese FDA (NMPA)



Pfizer

• Events Services
• 1 - 100 Employee

• Publishing Manager

  • Oct 2016 - May 2018

  Provide global regulatory operation support for global markets, including EU, US, APAC- Regulatory Dossier Management & eCTD Publishing: Compile, publish and manage global regulatory submission dossiers in ICH technical format- Life-cycle Maintenance: Coordinate with global product development teams throughout all phases to ensure timely regulatory activities- New Product Launch: Participate in and manage projects of the regional product launch, which contains full ICH modules and over 5000 files- Advertising and Labeling Review / FDA 2253: Submit FDA Form 2253, review and approve promotional labeling and advertising materials- Regulatory Information System:Use information management systems (e.g. Veeva Vault RIM) and validation tools (e.g. ISI Toolbox) to ensure regulatory compliance- Workflow Monitoring: Promote initiatives in tracking the progress of the implementation of new systems, processes, and services