Catherine Rowe joined Greenleaf Health as Director of Operations, Medical Devices and Combination Products, with more than 18 years of professional experience. Catherine is responsible for managing multiple processes, including supporting, scheduling, and general operations management for members of Greenleaf’s team.

Before joining Greenleaf in 2014, Catherine served as a Senior Project Manager in the Operations Department at The Martin Agency, a top-five global advertising firm. In this role, Catherine managed multiple projects, including planning, scheduling, and training to implement a companywide workflow software platform.

Immediately preceding her work at The Martin Agency, Catherine was the Director of Operations for Game Consulting Group LLC and Movieswap LLC, video game and movie resellers. In this role, she cultivated multiple vendor relationships while managing the corporate budget and overseeing all product logistics. During her time at Game Consulting Group, Catherine contributed to sales growth from startup to more than $6.1M. Before her experience with Game Consulting Group LLC and Movieswap LLC, Catherine served as an Executive Assistant for more than 12 years to the President of Phillips Sales Inc., a company that represented manufacturers specializing in consumer entertainment. While in this role, she coordinated nationwide trade shows and assisted in managing a large customer base of software retailers.

Catherine began her career as a Marketing Coordinator for Pearl Izumi, a cycling apparel company, where she executed marketing media programs and organized industry trade shows.

Catherine is a graduate of The University of Virginia.

Heather Rosecrans brings more than 40 years of public health and medical device experience to Greenleaf. She continues her commitment to public health by providing strategic consulting services and working with Greenleaf clients to deliver innovative devices to patients.

Before joining Greenleaf, Heather served as Director of the 510(k) Premarket Notification Staff at the FDA’s CDRH. In this role, she was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions, and other premarket regulatory requirements.

Heather started her FDA career as a biologist in the Bureau of Medical Devices. In 1980, she joined the newly organized CDRH Premarket Application (PMA) Staff. For the next 7 years, she coordinated the administrative, scientific, and regulatory review of PMAs, as well as product development protocols, master files and associated submissions.

In 1987, Heather joined the 510(k) Section of CDRH’s Program Operations Staff. In this role, she served as a Consumer Safety Officer and was a key contact for CDRH and within FDA on 510(k) matters. Heather held this position until 1992, when she became Director of the 510(k) Staff.

Heather’s accomplishments include drafting guidance documents and regulations on the 510(k) Program, training FDA staff and other stakeholders as well as assisting in the implementation of the Medical Device User Fee Modernization Act, the Food and Drug Administration Modernization Act and the Safe Medical Devices Act.

Heather’s extensive experience at CDRH—specifically her pivotal role in developing the 510(k) Program—enabled her to become one of the nation’s leading 510(k) experts. Since its inception in 1976, more than 150,000 510(k)s for devices have been reviewed for a determination regarding substantial equivalence via the program.

Heather has represented and spoken on behalf of CDRH in multiple forums, including national conferences, FDA advisory committee meetings, and international symposiums. Her published work includes numerous guidance and regulatory documents. She has also worked collaboratively with the Center for Medicare and Medicaid Services and other regulatory agencies.

Heather holds a B.S. in Biology from Pfeiffer College in Misenheimer, N.C.