Catherine Rowe

Executive Director of Operations, Medical Devices and Combination Products

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.

Brooke Roth

Executive Director, Finance

Brooke Roth serves as the Executive Director of Finance at Greenleaf Health. In collaboration with Greenleaf’s CFO, Brooke manages all of the firm’s financial matters. Brooke’s career experience spans numerous aspects of financial services and fundraising, bringing strong fiscal, analytical, and business expertise to her position at Greenleaf.

Before joining Greenleaf Health, Brooke was the Managing Director of Fundraising at the National Association of REALTORS (NAR), the nation’s largest trade association. The REALTORS® Political Action Committee (RPAC) is the #1 contributor to federal candidates in the country. Brooke also oversaw the growth of the President’s Circle Program—a direct-giver program that raised more than $1.3 million and is the nation’s largest direct-giver program to candidates. She also managed RPAC’s corporate, soft dollar fundraising, which was used for the association’s independent expenditures at the national, state, and local levels. In addition to fundraising, Brooke managed a $3M+ budget, fundraising staff, and consultants.

Before joining NAR, Brooke worked at a Washington, DC firm that raised money to support numerous candidates for the United States Senate. She also spearheaded DC events for candidates such as former Governors Matt Blunt (MO) and Arnold Schwarzenegger (CA). Additionally, Brooke consulted with nonprofit organizations, such as the American Cancer Society and National Football Foundation, on their fundraising strategies. In Washington, Brooke worked on Capitol Hill for then Congressman Robin Hayes (R-NC).

Earlier in her career, Brooke worked for a political consulting firm in Atlanta, GA, where she consulted for congressional campaigns regarding their fundraising strategies. She planned fundraising events with VIPs such as President George Bush, Vice President Dick Cheney, and the late Senator Fred Thompson. Brooke’s first foray into politics was as Finance Director for Senator Saxby Chambliss’s last congressional race before running for the US Senate.

Brooke earned her B.A. degree from Mercer University in Macon, GA. Brooke also completed coursework at George Washington University’s Graduate School of Political Management in Washington, DC.

Heather Rosecrans, F.R.A.P.S

Executive Vice President, Medical Devices and Combination Products

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.

Maura M. Norden, J.D.

Executive Vice President, Medical Devices and Combination Products and General Counsel

Maura Norden joined Greenleaf from the law firm Sidley Austin LLP in January 2015, following nearly a decade advising leading medical device and drug companies and investors on a broad range of FDA regulatory matters.

Maura uses her comprehensive and in-depth understanding of the FDA’s statutory jurisdiction, regulatory requirements, and regulatory processes to provide strategic advice to FDA-regulated companies throughout the product lifecycle, from development to FDA premarket review and postmarket regulation. Maura advises a broad range of clients, including early-stage companies, large, multinational industry leaders, trade associations, and public health organizations.

More specifically, Maura’s experience includes advising:

  • A range of life sciences companies regarding regulation by and engagement with the FDA during the COVID-19 pandemic;
  • In vitro diagnostic (IVD) companies on product development, regulatory pathway questions, and premarket review issues;
  • Consumer technology companies with respect to potential FDA regulation under the medical device provisions of the Federal Food, Drug, and Cosmetic Act;
  • Clinical laboratory clients regarding the FDA’s historical and current policies related to laboratory-developed tests (LDTs); 
  • Digital health companies on the FDA’s evolving approach to digital health products;
  • FDA-regulated firms on compliance with FDA promotional requirements, drawing on experience gained during temporary assignments to multinational pharmaceutical companies, where she sat on copy review committees;
  • Cosmetics companies with respect to permissible claims for cosmetic products; 
  • Investors by providing strategic advice and conducting regulatory assessments in connection with due diligence for transactions and working with investors post-acquisition on integration activities; and
  • Trade associations and other public-health-focused organizations developing positions on various FDA policies, reports, proposed rules, and guidance documents.

Maura received her J.D., with honors, from the George Washington University Law School where she was an associate of The George Washington International Law Review. She received her B.A. from the University of Virginia where she was a Jefferson Scholar.

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