Joanna Hipolito

Regulatory Affairs Manager @Horiba Instruments Inc

Irvine, CA, US

Lead clinical trials strategy and operations in support of FDA 510(k) submissions, including acting as Project Manager and Clinical Trials Manager; successfully contributed to a cleared hematology analyzer submission.Oversee clinical study design, protocol development, site management, and monitoring activities, ensuring compliance with FDA, GCP, and ICH standards.Collaborate cross-functionally with Regulatory Affairs, Clinical Affairs, Quality Assurance, and external sites to drive successful clinical trial execution and regulatory submissions.Serve as primary liaison with clinical sites, regulatory bodies, and key internal stakeholders, maintaining strong communication and operational oversight.Develop and manage clinical trial budgets, ensuring strategic financial stewardship and alignment with corporate objectives.Identify regulatory risks and implement proactive mitigation strategies to support regulatory compliance and operational success.Analyze regulatory trends and market intelligence to inform clinical strategy and ensure global regulatory readiness.