Maureen O’Connell is a regulatory affairs professional specializing in FDA medical device regulatory affairs and clinical study management. She has a proven track record in strategic planning, preparation, and administration of FDA premarket device submissions and associated clinical trials including pre-submissions, PMA’s, 510(k)’s, IDE’s, and request for designations (RFD), leading to FDA marketing approval of Class II and Class III medical devices and combination drug/device products. With over 25 years of experience, Ms. O’Connell was Vice President, Regulatory and Clinical Affairs at a Class III ophthalmic medical device company and has been a consultant since 1997. She has assisted medical device firms in a variety of therapeutic areas including ophthalmology (light based devices, intraocular lenses, diagnostics and software products), respiratory, general surgery, orthopedics, dermatology, cardiovascular, and dental. She also has experience managing large Phase II, Phase III and post approval clinical studies including preparation of clinical trial documents including study design, study management, and clinical study report writing.