Karen Jaffe

Karen Jaffe joined MannKind in 2020, bringing more than 25 years of technology project management and regulatory strategy experience to the company's innovative product and medical device development focus.

Karen's first introduction to MannKind and its innovative approach goes back 10 years when she served two years working in regulatory affairs at the Alfred Mann Institute. During her tenure at Al Mann Institute, she worked closely with Al’s daughter to promote legislation for an additional regulatory pathway for conditional approval for drugs to treat for threatening diseases. She came to MannKind from Keystone Heart where she was Vice President of Regulatory Affairs, Quality Assurance and Clinical Affairs. She previously served as Senior Director of Regulatory Affairs and Quality Assurance for NuVasive Specialized Orthopedics and at Obalon Therapeutics as well as consulted for Edwards LifeSciences.

A holder of two U.S. patents in pharmacovigilance, she is a member of the Orange County Regulatory Association, the Regulatory Affairs Professionals Society and the Drug Information Association.