Professional Summary
Professional Overview
Christine Ehmann is an accomplished Director of Regulatory Affairs with over 25 years of experience in the medical device and pharmaceutical industries. She specializes in navigating complex regulatory landscapes, ensuring compliance, and driving strategic initiatives that support business growth.
Experience Summary
Current Role
As the Director of Regulatory Affairs at Gynesonics, Inc., Christine is responsible for overseeing all regulatory compliance and approval processes for the company's innovative medical devices. She leads a team of regulatory professionals, collaborating closely with cross-functional stakeholders to ensure timely and successful product submissions to global regulatory bodies, including the FDA and international equivalents.
Career Progression
Throughout her career, Christine has held progressive regulatory affairs and quality management roles at esteemed organizations such as Teleflex Medical OEM, Thermo Fisher Scientific, Rochester Precision Optics, Corning Incorporated, Carestream Health, and Eastman Kodak. She has consistently demonstrated the ability to identify and mitigate regulatory risks, implement robust quality systems, and guide the successful commercialization of medical products in both domestic and international markets.
Academic Background
Christine holds a Bachelor of Science degree in Chemistry from the University of Rochester, where she graduated with distinction. She has also completed specialized training in regulatory affairs, quality systems, and project management, further strengthening her expertise in the medical device and pharmaceutical fields.
Areas of Expertise
- Regulatory strategy and compliance
- Quality systems design and implementation
- Global product registration and approval processes
- Cross-functional collaboration and stakeholder management
- Regulatory risk assessment and mitigation
- Continuous improvement and process optimization
Professional Impact
In her previous roles, Christine has led several high-profile regulatory initiatives that have resulted in the successful market introduction of innovative medical devices and pharmaceutical products. Her expertise in navigating complex regulatory landscapes has enabled her employers to maintain a competitive edge, while ensuring patient safety and adherence to industry standards.
Conclusion
With her extensive experience, strong technical acumen, and proven track record of regulatory success, Christine Ehmann is poised to make a significant impact in her current role at Gynesonics, Inc. As the Director of Regulatory Affairs, she is committed to driving the company's regulatory strategy, upholding quality standards, and contributing to the development of life-changing medical solutions.
