Professional Summary
Professional Overview
Christine Ehmann is an experienced regulatory affairs professional with a proven track record of driving compliance and strategic initiatives within the medical device and life sciences industries. As the Director of Regulatory Affairs at Gynesonics, Inc., she is responsible for leading the company's regulatory strategy, managing global submissions, and ensuring product alignment with evolving industry standards.
Experience Summary
Current Role
As the Director of Regulatory Affairs at Gynesonics, Inc., Christine is responsible for overseeing the company's regulatory affairs function, including managing global product registrations, coordinating with regulatory bodies, and maintaining compliance with relevant regulations. She plays a pivotal role in aligning the company's product pipeline with regulatory requirements, ensuring timely market access for Gynesonics' innovative medical devices.
Career Progression
Christine's comprehensive regulatory affairs expertise has been honed through her diverse professional experiences. Prior to her current role, she held various managerial positions at leading organizations, including Teleflex Medical OEM, Thermo Fisher Scientific, Rochester Precision Optics LLC, Corning Incorporated, Carestream Health, and Eastman Kodak. Throughout her career, she has consistently demonstrated her ability to navigate complex regulatory landscapes, implement robust quality systems, and drive continuous improvement initiatives.
Academic Background
Christine holds a Bachelor of Science degree in Biomedical Engineering from the University of Rochester, where she specialized in medical device design and development. Her strong academic foundation, combined with her extensive industry experience, has equipped her with the multifaceted skills required to excel in the regulatory affairs domain.
Areas of Expertise
- Regulatory strategy development and implementation
- Global regulatory submissions and approvals
- Quality management system design and optimization
- Compliance auditing and risk management
- Cross-functional collaboration and stakeholder management
- Industry best practices and regulatory trends analysis
Professional Impact
During her tenure, Christine has led the successful global registration of several medical devices, contributing to her employers' market expansion and revenue growth. She has also been actively involved in industry organizations, sharing her expertise through presentations and publications. Her dedication to regulatory excellence and commitment to innovation have made her a respected thought leader in the medical device industry.
Conclusion
With her exceptional regulatory affairs expertise, strategic mindset, and track record of transformative achievements, Christine Ehmann is poised to continue driving Gynesonics' regulatory compliance and business growth. Her versatile skillset and deep industry knowledge position her as a valuable asset in navigating the evolving regulatory landscape and delivering innovative solutions that improve patient outcomes.
