Daniel Schultz, M.D., F.A.C.S.

Principal, Medical Devices and Combination Products

Dr. Daniel Schultz joined Greenleaf following a distinguished 35-year career devoted to supporting and advancing Americans’ public health as a physician, teacher, Food and Drug Administration (FDA) official, and member of the US Public Health Service (USPHS). He has been recognized many times for his contributions and dedication to public health.

Dan continues his commitment to public health at Greenleaf as Principal of Medical Devices & Combination Products, where he provides strategic consulting services and works with Greenleaf clients to bring safe and innovative devices to patients.

As Director of the Center for Devices and Radiological Health (CDRH) at FDA from 2004–2009, Dan was responsible for seven FDA offices and more than 1,000 agency employees. He led the development, implementation, and evaluation of regulatory policies concerning medical devices and radiation-emitting products.

Dan began his 15-year FDA career in 1994 as a Medical Officer in the General Surgery Devices branch of the CDRH’s Office of Device Evaluation. In 1995, he advanced to Chief Medical Officer in the Office of Device Evaluation in the division of Reproductive, Abdominal, ENT, and Radiological Devices. He served as Division Director from 1998–2001. Dan became Deputy Director for Clinical and Review Policy in the Office of Device Evaluation in 2001 and Director of the Office of Device Evaluation the following year.

During his time at FDA, Dan took advantage of his medical knowledge and experience as Assistant Professor of Surgery at the Uniformed Services University of the Health Sciences and as a member of the Surgical Staff at the National Naval Medical Center in Bethesda, MD.

Before joining FDA, Dan served as a member of USPHS. During postings at Indian Health Service hospitals in Arizona and New Mexico, he provided medical care for people living in the Navajo Nation and Indian Pueblos. Dan received multiple awards for his service, including the Public Health Service Outstanding Medal.

A New York City native, Dan is a graduate of the City College of New York. He received his M.D. from the University of Pittsburgh and is board certified in Surgery and Family Practice.

Catherine Rowe

Executive Director of Operations, Medical Devices and Combination Products

Catherine Rowe has more than 25 years of professional experience in project management, marketing, and sales. At Greenleaf, Catherine is responsible for managing client relationships and contracts, as well as general operations, for the Medical Device and Combination Products 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.

Prior to that experience, 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, F.R.A.P.S

Executive Vice President, Medical Devices and Combination Products

Heather Rosecrans has more than 45 years of public health and medical device experience. She continues her commitment to public health by providing strategic consulting services and working with Greenleaf clients to bring innovative devices to the U.S.

Before joining Greenleaf, Heather served as Director of the 510(k) Premarket Notification Staff at the FDA’s Center for Devices and Radiological Health (CDRH). 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 seven 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 the 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—has made her one of the nation’s leading 510(k) experts. Since the program’s inception in 1976, the FDA has reviewed more than 150,000 device 510(k)s for a determination regarding substantial equivalence.

Heather represented CDRH in multiple forums, including national conferences, FDA advisory committee meetings, and international symposiums. While at the FDA, she worked collaboratively with the Centers for Medicare and Medicaid Services and other regulatory agencies. Her published works include numerous guidance and regulatory documents. Heather continues to speak on matters related to FDA premarket regulation of medical devices.

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 & 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 groups.

More specifically, Maura’s experience includes advising:

  • Digital health companies on the FDA’s evolving approach to digital health products;
  • 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); 
  • 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;
  • Trade associations and other public-health-focused organizations developing positions on various FDA policies, reports, proposed rules, and guidance documents;
  • In vitro diagnostic (IVD) companies on product development, regulatory pathway questions, and premarket review issues; and
  • A range of life sciences companies regarding regulation by and engagement with the FDA during the COVID-19 pandemic.

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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