James Paul Swink
Senior FDA leader with two decades of regulatory affairs, advisory committee leadership, and medical device expertise — now applying that same discipline to public health technology.
Professional Profile
With over 22 years of experience at the Food and Drug Administration (FDA), James Swink has built a distinguished career in regulatory affairs, leadership, and advisory processes. Throughout his tenure, James has exemplified exceptional expertise and dedication, making significant contributions to public health and regulatory excellence.
In his role as a Team Lead and Designated Federal Officer (DFO), James demonstrated outstanding organizational skills and leadership, ensuring that advisory meetings were efficiently structured and that stakeholders engaged in meaningful and productive discussions. His ability to navigate complex regulatory frameworks with clarity and professionalism has earned him respect among colleagues and industry partners alike.
Beyond his technical acumen, James fosters a collaborative and inclusive team environment, promoting innovation, problem-solving, and open communication. His guidance and strategic insights have helped teams deliver impactful recommendations and drive positive change within the regulatory landscape.
James Swink is a highly capable leader whose experience in advisory roles and regulatory frameworks makes him an invaluable asset to any organization seeking expert guidance and leadership in FDA-related matters.
By the Numbers
Career Highlights
Regulatory Consultant — Medical Devices
Provides expert guidance to medical device companies navigating the FDA's regulatory landscape. Helps clients align product development with regulatory expectations across 510(k), PMA, De Novo, IDE, and HDE pathways. Draws on 22 years inside CDRH — having run all Medical Device Advisory Committees, developed SOPs, trained new DFOs, and authored the CDRH Guidance for Advisory Committee meetings.
Advisory Committee Director — FDA / CDRH
Managed and trained all CDRH Designated Federal Officers and oversaw all six CDRH Advisory Committees. Directed planning, coordination, and execution of every CDRH AC meeting, and handled sensitive Conflict-of-Interest screening for panelists. Led 150+ Medical Device Advisory Committee meetings producing structured, productive discussions on device safety and effectiveness — earning a 95% satisfaction rate from FDA and external stakeholders alike. Built and delivered regulatory training for FDA divisions, leadership, and medical professionals on the advisory committee process, pathways to market, and medical device law.
Designated Federal Officer (DFO) — FDA
Served as DFO for three Advisory Panels: Circulatory System Devices, Ear Nose & Throat Devices, and Molecular & Clinical Genetics. Established panel-track timelines, drafted public meeting summaries for the FDA website, and authored the DFO Manual and Standard Operating Procedures still used to standardize processes across the agency.
Executive Secretary — Division of Cardiovascular Devices
Coordinated recruitment of Special Government Employees and directed nine panel meetings between December 2006 and November 2007. Built the Circulatory System Devices Consultant database and established SOPs for justification criteria for government and consultant attendance.
Project Manager — Division of Cardiovascular Devices
Managed the division's travel and training budget, monitored premarket application progress, and partnered with regulatory staff to schedule meetings and deliver agendas and materials on time.
Published FDA Documents
- FDA Guidance Document: Procedures for Meetings of the Medical Devices Advisory Committee (2017)
- FDA Manual: Designated Federal Officer Manual
- FDA SOP: Advisory Committee Preparation SOP for Divisions
- FDA Workgroup: FDA Advisory Committee Policy and Guidance Handbook
Areas of Expertise
Education
University of Maryland, College Park — B.S. Physiology and Neurobiology, Magna Cum Laude (GPA 3.5/4.0), May 2003
Beyond the FDA
James is the founder of SoberSave and Swink Apps — applying the same rigor and care for public health he brought to the FDA toward consumer wellness, mindful drinking, and personal-finance tools that help people invest in themselves.