School
School of Professional Studies
Department
School of Professional Studies
About
Christopher Fulmer is a regulatory affairs professional and Regulatory Affairs Lecturer with extensive experience in regulatory strategy, compliance, and regulatory writing within healthcare and life sciences. After nearly two decades practicing regulatory law, he transitioned into regulatory affairs leadership, bringing deep expertise in navigating complex regulatory environments.
He holds multiple credentials, including RAC (Devices), an MSc in Regulatory Affairs, an MBA, a JD, and an LLM. A published author and lecturer, Christopher focuses on helping organizations develop effective regulatory strategies, manage compliance risk, and support innovation in the development of medical products and technologies.
Education
- MS, Regulatory Affairs for Drugs, Biologics, and Medical Devices, Northeastern University
- LLM, American Banking Law Studies, Boston University School of Law
- JD, Stetson University College of Law
- MBA, University of Maine
- BBA, Finance, Stetson University
- Regulatory Affairs Certification (RAC) in Devices
Featured Affiliations
Regulatory Affairs Professionals Society
WebsiteEducation
- MS, Regulatory Affairs for Drugs, Biologics, and Medical Devices, Northeastern University
- LLM, American Banking Law Studies, Boston University School of Law
- JD, Stetson University College of Law
- MBA, University of Maine
- BBA, Finance, Stetson University
- Regulatory Affairs Certification (RAC) in Devices
Publications
- Medical Device Cybersecurity Requirements in the USA, Journal of Medical Device Regulation, August 2023, Volume 20, Issue 2, https://globalregulatorypress.com/product/august-2023-volume-20-issue-3/
- Cybersecurity Challenges and Opportunities for Medical Device Companies in 2022, Journal of Medical Device Regulation, podcast with Dr. Kevin Fu, the FDA‚' Acting Director of Medical Device Cybersecurity, March 10, 2022, https://globalregulatorypress.com/services/medical-device-podcasts/
- Regulating the Advertising and Promotion of Tobacco Products: Where Are We Now?, Food and Drug Law Journal, Volume 76, Issue 3, December 2021
- Is regulatory change by the USA FDA inevitable in medical device servicing?, Journal of Medical Device Regulation, May 2021, Volume 18, Issue 2, https://globalregulatorypress.com/product/may-2021-volume-18-issue-2/#english
- Real World Evidence: A Potential Solution, Update Magazine ‚– a Food and Drug Law Institute publication, Winter 2020 Issue, https://www.fdli.org/2020/11/real-world-evidence-a-potential-solution/ and https://www.fdli.org/resources/update-magazine/
- The evolving regulation of software as a medical device in the USA, Journal of Medical Device Regulation, November 2020, Volume 17, Issue 4, https://globalregulatorypress.com/product/november-2020-volume-17-issue-4/
- AT&T Family Federal Credit Union v. First National Bank and Trust Company, 522 U.S. 479 (1998)– assisted in the research and drafting of the National Credit Union Administration‚' Amicus Brief