Mark Kramer

Executive Vice President, Medical Devices and Combination Products

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. 

Maria Bonner

Vice President, Regulatory Compliance and Deputy General Counsel

Maria is a Vice President in Greenleaf’s regulatory compliance group, where she provides strategic and regulatory advice to clients. Maria also serves as Greenleaf’s in-house Deputy General Counsel. 

Prior to joining Greenleaf, Maria gained policy and legal experience in both the private and public sectors. She formerly served at the White House in several roles. She served on the Domestic Policy Council as Deputy Director and Special Assistant to the President. Maria also served as the Deputy Associate Counsel in the Office of the Vice President. 

Maria’s previous private sector experience included consulting and legal roles. Maria was at Greenleaf in the regulatory compliance group. 

She formerly was at a global law firm in the litigation and international arbitration group. Before pursuing her law degree, Maria was an Analyst at an international business and economic public policy consultancy. She worked principally with the Managing Directors, former administration alumni including a President’s Chief of Staff, in providing key policy advice to clients.

Maria earned her J.D. from Georgetown University Law Center and her B.A. from Georgetown University, graduating summa cum laude and Phi Beta Kappa. 

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

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.

Madeleine Giaquinto, J.D.

Director, Regulatory Affairs

Madeleine Giaquinto offers a robust portfolio of public health policy and regulatory compliance expertise that spans a career of nearly 10 years working across legal, government/legislative affairs, and hospital administrative environments.

At Greenleaf Health, Madeleine helps clients navigate complex landscapes of FDA regulation, policy, guidance, and GXP standards for drugs, biologics, medical devices, dietary supplements, cannabidiol (CBD) and cannabis-derived products, cosmetics, and tobacco-related products. She advises clients through strategic engagement with the FDA on wide-ranging compliance issues, such as remediating deficiencies identified in FDA Form 483s and warning letters and building mature quality management systems.

Madeleine has spoken on panels and published articles analyzing the regulatory impacts of a host of timely topics, including root causes of drug shortages, FDA warning letter trends, implementation of the Drug Supply Chain Security Act (DSCSA), advanced and continuous drug manufacturing technologies, and the development of a regulatory framework for CBD and cannabis-derived products. She serves on the Food and Drug Law Institute’s (FDLI) Austern Writing Awards Committee, focused on fostering the next generation of professionals in the food and drug law field.

Prior to joining Greenleaf Health, Madeleine worked on legal and government relations teams at 340B Health, a membership organization of hospitals and health care systems that participate in the federal 340B drug pricing program. Her role involved researching and analyzing implications of 340B program development, and educating members on program compliance, implementation, and advocacy strategies. Madeleine also previously worked at Mintz Levin Strategies, LLC, where she tracked and analyzed development of various federal and state health care bills and policies. She has also spent time in health care practices managing compliance with practitioner credentialing requirements of federal, state, and local regulatory authorities.

Madeleine has a B.S. in biology from Georgetown University and a J.D. from George Mason University School of Law.

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

Executive Vice President, Regulatory Compliance & Deputy General Counsel

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

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

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.

Cynthia Schnedar

Principal, Regulatory Compliance

With more than 30 years of experience as an expert in compliance issues – including more than 20 years in leadership positions in the government – Cynthia adds to Greenleaf Health’s prestige as Principal, Regulatory Compliance.

Cynthia was formerly Director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research (CDER), where she led regulatory enforcement efforts to ensure companies comply with federal standards for quality and safety. Cynthia’s commitment to quality continues in her work advising Greenleaf clients on GCP and GMP issues across the product lifecycle.

In addition to serving at the FDA, Cynthia spent more than two decades at the Department of Justice (DOJ), where she specialized in compliance and enforcement issues. As Deputy Inspector General and Acting Inspector General, she led a nationwide staff in investigating allegations of corruption and misconduct and conducting independent audits of department programs. Through her other roles at DOJ, Cynthia acquired an extensive background in criminal and civil enforcement work, serving as Counselor to the Inspector General, Deputy Chief of the Sex Offense and Domestic Violence Section in the U. S. Attorney’s Office for the District of Columbia, Assistant U.S. Attorney, and Trial Attorney in the Civil Fraud Section of the Civil Division.

Previously, Cynthia clerked for the Honorable James R. Browning on the U.S. Court of Appeals for the Ninth Circuit and worked as a television reporter in New Mexico and Texas.

Cynthia earned a B.A., with distinction, from the University of New Mexico and a J.D., with honors, from the University of Texas School of Law.

Cynthia serves as a board member for both the Food and Drug Law Institute and the FDANews Editorial Advisory Board.

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.

13 records
  • 1
  • 2