Specialized in development of ophthalmic medical devices with strengths in clinical, regulatory and quality aspects. Has gained extensive experience in clinical research and clinical project management by leading high priority projects to successfully develop and launch best-in-class products in eye care business.
Has experience in building and defending regulatory strategies, as well successfully led and defended multiple internal and external audits, including FDA inspection and recall process.
Oversaw development of Human Factors Evaluations.
Has led high performing global, cross functional teams to respond to short term, immediate needs and developing strategies for long term sustainability by building R&D pipeline.
Proven success with Fortune 500 companies, as well as start-up firms.
Specialties:
Clinical product development, clinical operations, building and executing systems, strategies to streamline processes and improve efficiency.
Develop new strategic alliances and evaluating new technologies.
Organizational development.