Sneak Peek: Inside Our Advanced Strategic Communications Certificate Program for Regulatory Professionals

Nancy Singer, JD, LLM, RAC, FRAPS

President, Compliance-Alliance LLC

Nancy Singer is president of Compliance-Alliance LLC. She is on the faculty of George Washington University School of Medicine and Health Sciences and teaches classes for FDA Staff Colleges and FDA District Offices. Previously, she served as special counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA commissioner’s Special Citation. She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently she was a partner at the law firm of Kleinfeld, Kaplan and Becker. Nancy is a retired commander in the Navy Reserve.

: https://www.linkedin.com/in/nancysingerjd/

Richard J. DeRisio, MS

Principal, DeRisio Group, LLC

Richard DeRisio is a retired medical device executive who collaborates on the development and presentation of training courses for regulatory affairs and quality system professionals. Early in his career, Richard worked in FDA’s Washington-area headquarters offices supporting field operations, managing foreign inspections of medical device and pharmaceutical manufacturers and, in CDRH’s Office of Compliance, reviewing compliance actions, conducting industry training, and serving as the Office’s sterilization sciences expert. After serving at FDA, Richard led global and divisional clinical, quality, regulatory and government affairs organizations at Abbott, J&J, Covidien, and Pfizer, among other companies. His experience encompasses cardiothoracic, electrophysiology, robotic, ophthalmology, and wound healing devices. Prior to retiring, Richard was VP, Medical Health Services, Americas Region for the German notified body TÜV SÜD. In that role, Richard’s organization was responsible for CE-Mark approval of medical devices manufactured in North America.

: https://www.linkedin.com/in/richardderisio/

Rosanne Melikian, PhD, MSRS, RAC

Sr. Director, Regulatory Affairs, Johnson & Johnson MedTech Vision

Rosanne Melikian leads a global regulatory affairs team responsible for new product development and life cycle management of medical devices designed to treat cataracts and glaucoma. Her portfolio includes cataract extraction systems, laser cataract devices, intraocular lens implants and insertion systems and ophthalmic viscosurgical devices (OVDs).

Rosanne began her career at Abbott in a hybrid role that combined regulatory affairs with research science. She now oversees global regulatory approvals and life cycle management for Johnson & Johnson Surgical Vision’s largest business franchise. She is also committed to talent development within the regulatory affairs organization, has supported critical business development projects, and actively participates in US and international device standards meetings. Rosanne frequently presents to health authorities such as the FDA, Health Canada, and European notified bodies on novel technologies and clinical trials.

: https://www.linkedin.com/in/rosanne-melikian-phd-msrs-rac-044a31109/