Global Healthcare Innovation & Regulatory Leadership

Advised senior regulatory affairs executives on strategic decision-making and regulatory pathways for accelerated product approvals and CE Mark certifications across European markets under evolving EU MDR and IVDR regulations.

Managed original PMA submissions and contributed to obtaining FDA approval for the LifeVest Wearable Defibrillator within a record timeframe, supporting one of the most significant wearable cardiac protection technologies in the market.

Led regulatory documentation evaluations and quality management system assessments to ensure compliance with evolving FDA and EU regulations while supporting remediation and operational excellence initiatives.

Served as a subject matter expert in global regulatory strategy development, EU MDR labeling, and regulatory submissions for combination healthcare products, ensuring cross-functional alignment and global compliance excellence.

Led global regulatory submission strategies supporting NDA lifecycle management, biosimilar expansion studies, cell therapy regulatory documentation, and international market authorizations across multiple healthcare systems.

Developed innovative strategic concepts focused on pandemic preparedness, healthcare systems resilience, digital healthcare transformation, and medical supply chain optimization through advanced healthcare innovation frameworks.

Managed global regulatory remediation efforts, compliance strategies, submissions, and recall actions related to respiratory medical device defects and design modifications affecting international healthcare markets.

Managed global regulatory remediation efforts, compliance strategies, submissions, and recall actions related to respiratory medical device defects and design modifications affecting international healthcare markets.

Developed and implemented comprehensive regulatory strategies ensuring adherence to evolving healthcare laws, clinical research regulations, and international compliance standards. Established monitoring systems for regulatory inspections, audits, and policy management while guiding organizations through rapidly changing global healthcare environments.

Directed regulatory strategy initiatives for immunology and pulmonology assets, including Post-Marketing Commitments (PMCs), Health Authority interactions, and IND preparation activities. Served as Global and U.S. Regulatory Lead for early-stage healthcare programs, supporting regulatory strategy throughout the product lifecycle.

Led strategic bridge study initiatives supporting biosimilar product expansion into Japanese and Chinese healthcare markets. Coordinated regulatory pathways and global clinical alignment strategies designed to achieve successful marketing authorizations and commercialization within diverse international healthcare systems.

Managed the development and oversight of critical regulatory documentation supporting advanced cell therapy submissions, including clinical protocols, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and IND/NDA/MAA modules. Ensured full alignment with ICH standards and international regulatory requirements governing advanced therapeutic healthcare products.