Results-driven regulatory professional professional with extensive experience in leadership and strategic oversight. Adept at driving organizational success through effective team collaboration and dynamic problem-solving. Recognized for adaptability and keen focus on achieving objectives.
Ensures Regulatory Compliance with international and local regulations, represents the Diagnostics Division at trade association meetings and conferences and advocates in Abbott's interest. Leads, develops and mentors RA staff.
Ensures Regulatory Compliance in alignment with applicable regulations for China and Japan.
Led the China Acceleration project to reduce speed to market in compliance with country requirements for Medical Devices.
Role changed during the course of the years including responsibility for Commercial Business Operations and Project Management, Marketing and Clinical Affairs for a unique diagnostics technology (PCR and mass spec).
Successfully managed multiple R&D projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
Technical and scientific customer support
Team collaboration and leadership
Strategic leadership
Decision-making
Organizational development