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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. 

Conducting Due Diligence to Guide a Corporate Acquisition Decision

Greenleaf Health was engaged by a global medical device company to assist in conducting due diligence for the potential acquisition of another device company. Greenleaf’s Advisory Services Team evaluated the target company’s FDA compliance history and regulatory status, as well as their promotional and advertising materials, in order to assess the regulatory risk that would …

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.

John Taylor

President and Principal, Compliance and Regulatory Affairs
  • Background:
    • 20 years at the FDA
  • Specialty:
    • Regulatory policy, compliance, and enforcement
  • Experience:
    • Industry experience with medical device, biotech, and pharmaceutical sectors
  • Awards:
    • Health and Human Services Secretary’s Award for Distinguished Service (1997, 2000, 2003, 2004, 2005, 2011)
    • FDA Award of Merit (2000, 2003, 2005)

For more than 30 years, John Taylor has made significant contributions to the public health, serving in senior leadership positions within the Food and Drug Administration (FDA), industry, and consulting services. John joined Greenleaf following a distinguished career of more than 20 years at the FDA. During John’s time at the Agency, he led several of its priority initiatives. At Greenleaf, John continues his commitment to health care innovation as the firm’s President and Principal of Compliance and Regulatory Affairs, providing strategic consultation to FDA-regulated clients on enforcement and compliance matters.

From 2009 to 2014, John held three high-profile positions at the FDA: Counselor to the Commissioner, Acting Principal Deputy Commissioner, and Acting Deputy Commissioner for Global Regulatory Operations and Policy.

As Counselor to the Commissioner, John served as the principal advisor to Commissioner Margaret Hamburg on issues that affected the agency’s programs, policymaking, management, budget, and administration. In his role as Acting Deputy Commissioner for Global Regulatory Operations and Policy, John provided leadership and direction to more than 4,000 employees in the FDA’s Office of Regulatory Affairs (ORA) and Office of International Programs.

John began his career at the FDA in 1991 as an attorney within the Office of the Chief Counsel, responsible for all phases of criminal and civil litigation related to violations of the Federal Food, Drug, and Cosmetic Act and other federal laws. In 1997, John was promoted to Senior Advisor for Regulatory Operations and Policy within the FDA’s Office of the Commissioner. He was later named Director of the Center for Drug Evaluation and Research’s Office of Compliance. In 2000, John accepted the position of Director of ORA’s Office of Enforcement. Two years later, John was promoted to Associate Commissioner for Regulatory Affairs.

In 2005, John left the FDA to spend four years working in industry, first as Divisional Vice President for Federal Government Affairs at Abbott, then, in 2007, as Executive Vice President for Health at the Biotechnology Industry Organization.

John has worked closely with many professional associations, serving on the boards of the Food and Drug Alumni Association and the Food and Drug Law Institute. He currently serves on the United States Pharmacopeia Board of Trustees.

John received his J.D. from the College of William and Mary and is a graduate of Pennsylvania State University with a B.A. in History.

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.

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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