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Mark Kramer

Executive Vice President, Medical Devices and Combination Products
  • Background:
    • 17-year FDA career that included leading interdisciplinary review teams in CDRH and directing the Office of Combination Products | M.S., Biomedical Engineering
  • Specialty:
    • FDA regulation of combination products and medical devices
  • Experience:
    • Founding Director of the FDA's Office of Combination Products | 14 years as a strategic regulatory consultant for medical device, combination product, drug, and biological product clients

Mark Kramer is Greenleaf’s primary expert on combination products, providing clients with unique insight from his experience establishing and leading the FDA’s Office of Combination Products (OCP). As Director of OCP from 2002 to 2007, Mark oversaw the development of significant regulations, policies, and practices currently in effect for combination products, including the primary mode of action rule, the cGMP rule, the adverse event reporting rule, numerous guidance documents clarifying the regulation of combination products, and the intercenter consultation process. Mark also has a firsthand understanding, through his management of the FDA’s Product Jurisdiction Program, of how the Agency assigns combination products to Centers for review and determines the regulatory identity of drugs, devices, and biological products for which jurisdiction is unclear or in dispute.

Mark’s work at Greenleaf is informed by his training as a biomedical engineer and a career of more than 35 years in medical product regulation that has united technical, front-line regulatory skills with strategic advising and leadership. He ran an independent consulting practice for over 13 years (2009-2022), advising approximately 200 clients from across the globe, including sponsors of medical devices, combination products, drugs, and biological products, as well as breakthrough and orphan products. In addition to helping clients develop and refine their regulatory strategies, Mark supported sponsors’ regulatory submissions and FDA interactions at all stages of the regulatory process: authoring, strengthening, and submitting initial submissions; developing and critically reviewing responses to FDA-identified deficiencies; preparing for Agency and advisory panel meetings; and advising on cGMPs and adverse event reporting. Clients further benefited from his knowledge of FDA expectations for key device concerns, such as biocompatibility, electrical safety, electromagnetic compatibility, as well as his biomedical engineering background, which enhanced his reviews of design control documentation for devices and combination products. Mark has also served as an expert witness, testifying in depositions and trials, in a variety of litigation matters and provided regulatory expertise for due diligence activities.

During his 17 years at the FDA, Mark also gained extensive hands-on experience in device evaluation as a lead reviewer and supervisor for a broad range of products: cardiovascular, anesthesiology/respiratory, urology, gastroenterology, surgical, and dental. He managed interdisciplinary review teams as Chief of the Urology and Lithotripsy Devices Branch and as Chief of the Anesthesiology and Defibrillator Devices Branch of CDRH’s Office of Device Evaluation and directed the Center’s education and training programs for staff and industry. Beyond his deep experience at the Agency, Mark spent three years in industry as Chief Regulatory Strategist for GE Healthcare’s medical device business, with executive responsibility for regulatory strategies, processes, and decisions throughout the U.S., Canada, and Latin America.

Mark has served as a board member of the Regulatory Affairs Professionals Society (RAPS), and in 2021 was awarded the RAPS Founders Award. He is also a longstanding adjunct faculty member with the Regulatory Affairs Master’s Program at St. Cloud State University (Minnesota). He earned an M.S. in biomedical engineering from Rensselaer Polytechnic Institute in New York and a B.A. in mathematics from Rutgers College of Rutgers University. 

Providing Litigation Support That Led to a Favorable Judgment for a Device Start-Up Firm

A medical device start-up was involved in a commercial dispute against a large multinational device manufacturer and sought Greenleaf Health’s services as an expert witness and consultant on the FDA regulatory grounds for the case. Greenleaf’s litigation support team prepared an expert report that reinforced the client’s arguments regarding the likelihood that the FDA would …

Katherine Macaulay Mueller

Deputy General Counsel
  • Experience:
    • More than a decade of legal experience in the private sector

Katherine Mueller has more than a decade of legal experience in the private sector, most recently as First Vice President and Senior Counsel at SunTrust Banks, Inc., where she managed litigation nationally and advised default constituencies on risk mitigation.

Prior to working at SunTrust, Katherine was a partner at an Am Law 200 firm, where she had both corporate and litigation practices. In her corporate practice, she focused on asset sales and acquisitions and corporate tax planning. Katherine also represented financial institutions in secured lending transactions, including loan workouts and corporate restructurings. She also managed a national Chapter 11 bankruptcy case, leading a team that resolved hundreds of preference actions and bankruptcy claims.

Prior to law school, Katherine worked on Capitol Hill and at a government contracting firm where she was a technical writer and editor.

Katherine received a B.A. in history, with honors, from Trinity College and a J.D. from William and Mary Law School.

Kalah Auchincloss, J.D., M.P.H.

Executive Vice President, Regulatory Compliance & Deputy General Counsel
  • Specialty:
    • Regulatory compliance | Regulatory policy | Litigation support
  • Experience:
    • More than 15 years of food and drug legal, policy, and regulatory experience at the FDA, on Capitol Hill, and in the private sector

Kalah Auchincloss has more than 15 years of food and drug legal, policy, and regulatory experience at the FDA, on Capitol Hill, and in the private sector. Kalah spent six years at the FDA, including as Deputy Chief of Staff for two FDA Commissioners, Dr. Robert Califf and Dr. Scott Gottlieb. As Deputy Chief of Staff, Kalah worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Kalah was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office.

Prior to that role, Kalah spent time on Capitol Hill as the FDA detailee to the Senate Committee on Health, Education, Labor, and Pensions, working on the 21st Century Cures Act and other FDA-related legislation. She has also served in the FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the-counter drugs, and other enforcement issues.

Before joining the FDA, Kalah was an associate at the law firm Foley Hoag LLP, in the firm’s health care practice group.

As an Executive Vice President at Greenleaf, Kalah is continuing her commitment to public health by providing strategic counsel to clients on compliance, enforcement, and policy matters. Kalah counsels clients across a range of product sectors and is knowledgeable about multiple areas of FDA regulation, including drugs, compounding, unapproved drugs, diagnostics, digital health, cosmetics, and cell and gene therapy.

Kalah holds a B.A. with honors from Williams College, a J.D. with honors from Georgetown University Law Center, and an M.P.H. from Harvard University.

David Elder

Principal, Regulatory Compliance
  • Background:
    • 23 years with the FDA
  • Specialty:
    • Corporate quality systems; compliance strategies; inspection readiness
  • Experience:
    • Senior FDA regulatory official and retired Captain in U.S. Public Health Service

David Elder brings more than 35 years of extensive regulatory experience to his role as Principal, Regulatory Compliance at Greenleaf Health. A 23-year veteran of the U.S. Food and Drug Administration (FDA) and U.S. Public Health Service (USPHS), David served as a senior FDA official with prominent roles in domestic and foreign inspections, recalls and emergencies, and compliance actions involving hundreds of situations. He has testified in federal court and before Congress, initiated and approved enforcement actions, and represented the FDA during national media events. Additionally, David has received numerous honors, including the Distinguished Service Medal.

David began his FDA career as an Investigator in the Boston District Office where he conducted domestic and foreign inspections and investigations in various program areas. He was selected as a Compliance Officer and later as the Director of the Compliance Branch with responsibility for assessment of inspection reports, initiation of compliance actions, and evaluation of compliance action effectiveness.

David transferred to FDA headquarters when he was selected as the Director of the FDA Office of Enforcement in 2003, a position he held for the next six years. In this Senior Executive Service position, David led the Office with responsibility for agency enforcement policy, agency recall policy and operations, and enforcement strategy and case review. In 2009, David transferred from the Office of Enforcement to the Office of Regional Operations where he led the Office with responsibility for policy and operations related to foreign inspections, domestic inspections, import operations, and field science. In both roles, David served as a principal advisor to the FDA’s Associate Commissioner of Regulatory Affairs.

Prior to joining Greenleaf, David served as Vice President with PAREXEL International. He traveled to client locations across the U.S. and in 14 foreign countries to conduct audits and mock inspections; provide training, coaching, and mentoring; and advise clients on the development and communication of corrective actions that meet FDA expectations and that achieve and sustain compliance.

At Greenleaf, David continues to provide strategic guidance and support to pharmaceutical and medical technology companies in areas including: strengthening corporate quality systems; developing compliance strategies; supporting inspections and ensuring inspection readiness; assisting industry clients and legal counsel in developing and communicating corrective action plans in response to compliance issues; verifying completed corrective actions; executive training and coaching; and performing due diligence. David also communicates expert advice through presentations at FDA and industry conferences, articles published in industry journals, and FDLI’s 2022 book, How FDA Really Works: Insights from the Experts.

David received a B.S. in electrical engineering from Boston University and attended executive management courses at Harvard University.

Samantha Eakes

Vice President, Regulatory Affairs
  • Background:
    • Public health, public policy, and non-profit sector
  • Specialty:
    • FDA regulation of medical devices and combination products | Premarket medical device submissions
  • Experience:
    • 7+ years of FDA regulatory consulting experience

Samantha brings more than seven years of FDA regulatory consulting experience and a diverse background in public health, public policy, and the nonprofit sector to her position as Vice President of Regulatory Affairs.

Through her public health studies and prior experience, Samantha acquired critical public health knowledge that allows her to effectively assist clients with developing communications and advocacy strategies, stay informed on evolving regulatory requirements, and provide strategic insight on critical regulatory challenges.

In her role at Greenleaf, Samantha advises clients regarding potential FDA regulatory pathways for their devices and assists clients with their FDA submissions and correspondence. She reviews, drafts, and files FDA premarket submissions for medical device clients, including: Pre-Submissions (Pre-Subs); Submission Issue Requests (SIRs); Requests for Designation (RFDs); Breakthrough Device Designation Requests; Investigational Device Exemptions (IDEs); 510(k) Premarket Notifications; Premarket Approval Applications (PMAs); and Emergency Use Authorizations (EUAs). Samantha also conducts research for medical device clients to use in strategic planning and analyzes the regulatory landscape using FDA databases, regulations, policies, and guidance documents.

Samantha has published articles on medical device-related topics such as cybersecurity and the FDA’s least burdensome provisions.

Prior to joining Greenleaf, Samantha gained policy and advocacy experience at Management Sciences for Health (MSH). She also previously volunteered with Arts for Dementia, an organization in London, England, that provides art and music therapy for individuals living with dementia and Alzheimer’s disease.

Samantha earned a B.A. in psychology from Boston University and an M.P.H. from Boston University’s School of Public Health.

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

Principal, Medical Devices and Combination Products
  • Background:
    • 20 years as a practicing physician/surgeon, 15 years at CDRH FDA regulating medical devices in the US and over a decade as Principal for Medical Devices and Combination Products at Greenleaf Health
  • Specialty:
    • Specialist in medical devices and combination products
  • Experience:
    • Patient care, device regulation at multiple levels within CDRH, consulting for industry on medical device regulation in the US

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
  • Background:
    • More than 25 years of marketing, sales, and project management experience
  • Specialty:
    • Marketing and operations

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
  • Background:
    • 30-plus years with the FDA’s Center for Devices and Radiological Health (CDRH) and over a decade as Executive Vice President for Medical Devices and Combination Products at Greenleaf Health
  • Specialty:
    • FDA’s 510(k) program, the 513(g) program, classification and reclassification, De Novo petitions, and other premarket regulatory requirements
  • Experience:
    • Extensive experience in FDA premarket review processes for medical devices | Device regulation at multiple levels within the FDA and consulting for industry on medical device regulation in the U.S.

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
  • Background:
    • More than 15 years advising FDA-regulated entities, investors, and public health organizations on a broad range of FDA regulatory matters
  • Specialty:
    • FDA statutes, regulations, and policy | Development, clearance and approval, and marketing of FDA-regulated products | FDA regulation of in vitro diagnostics and laboratory-developed tests | FDA regulatory due diligence | FDA regulation of digital health
  • Experience:
    • Joined Greenleaf after almost a decade of professional experience in the food, drug, and medical device practice group at a large, multinational law firm

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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