Karen Kelso, Ph.D., has been named regulatory affairs director, focused on cardiovascular medical devices, at Novella Clinical. Dr. Kelso has extensive regulatory experience in global markets for all medical device classifications (I, IIa, IIb and III).
Dr. Kelso will drive regulatory and clinical strategy for multinational programs. She has achieved numerous CE Marks and has written, submitted, and cleared multiple 510(k)s with the FDA. Her experience also includes several pre-IDE submissions and IDE approvals.
Dr. Kelso joins the company after 16 years with Vascutek, a Terumo Company in Scotland, where she most recently served as vice president regulatory affairs and clinical studies for the company’s portfolio of vascular products. She previously held positions in R&D.
Novella Clinical’s Global Head of Regulatory Affairs, Kevin Johnson, said, “Karen’s regulatory experience in the U.S., Europe and Asia and her relationships with international agency officials will greatly benefit Novella’s medical device clients, many of whom are seeking to expand clinical trials to international markets.”