Maureen O’Connell

Maureen O’Connell is the President of O’Connell Regulatory Consultants, Inc., a firm specializing in medical device regulatory affairs and clinical study management. She has a proven track record in strategic planning, preparation, and administration of all Food and Drug Administration premarket device submissions and associated clinical trials including Premarket Approval applications, 510(k) Premarket Notifications, and Investigational Device Exemptions leading to FDA marketing approval of Class II and Class III medical devices and combination drug/device products. Since founding O’Connell Regulatory Consultants, Inc. in 1997, Ms. O’Connell has assisted medical device firms in a variety of therapeutic areas with a specialty in ophthalmology and light based devices. From 1988 to 1997, at Summit Technology, Inc., Ms. O’Connell held a number of roles in the regulatory and clinical affairs groups culminating with responsibility for worldwide regulatory affairs, clinical study management and clinical education functions as Vice President, Regulatory and Clinical Affairs.