Kevin E. Daly, RAC

Kevin E. Daly, RAC has extensive experience in regulatory affairs, clinical affairs, and quality management in the medical device industry. Kevin E. has held various leadership positions in renowned companies throughout their career.

In 1992, Daly joined AccuLase, Inc. as Vice President and later became a Director. Kevin E. was responsible for overseeing all plant operations for the Class III excimer laser angioplasty manufacturer.

Daly worked as a Principal at InterVentional Technologies, Inc., a coronary atherectomy and angioplasty balloon manufacturer, where they coordinated regulatory programs and submissions. Kevin E. also served as a Principal Consultant at their self-owned firm, assisting both InterVentional Technologies, Inc. and AccuLase, Inc. with their regulatory programs and submissions.

From 1996 to 1998, Daly held the position of Director of Regulatory Affairs and Compliance Standards at InterVentional Technologies, Inc. In this role, they directed regulatory, clinical, and quality assurance programs for the manufacturing of Class II and III cardiovascular catheters.

Prior to this, in 1998, Daly joined Medtronic Intervascular Vascular and served as the Director of Regulatory and Clinical Affairs. Kevin E. led global regulatory and clinical programs for the manufacturer of Class II and III intravascular stent and angioplasty devices.

At MicroTherapeutics, Inc. (d/b/a ev3 Neurovascular/Medtronic) from 1999 to 2002, Daly held the position of Vice President of Regulatory/Clinical/Quality. Kevin E. led regulatory, clinical, and quality assurance programs for Class II and III neurovascular implants and delivery systems.

From 2002 to 2007, Daly worked as the Chief Operating Officer (COO) at TheraLight, Inc., a manufacturer of Class II, software-controlled, electro-optical equipment for skin disease treatment. Kevin E. established sales and distribution channels and obtained FDA 510(k) clearances and CE Mark for the company's products.

Daly then joined MicroVention Terumo in 2007 as the Vice President of Regulatory Affairs and Quality Assurance. Kevin E. was responsible for regulatory programs supporting global commercialization of FDA Class III neurovascular stents, Class II neuroembolization devices, and vascular access devices.

In 2012, Daly co-founded CXL Ophthalmics, where they served as the President and Chief Operating Officer. CXL Ophthalmics is a medical device and pharmaceutical company focusing on developing products and technologies for the treatment of eye structures weakened by disease. Daly played a key role in the company's success, overseeing regulatory, clinical, and quality aspects.

In 2014, Daly joined CXL Ophthalmics again, this time as SVP of Device Development & Regulatory Affairs. Additionally, in the same year, they started working as a Principal Consultant for Regulatory/Clinical/Quality for medical devices and combination products.

Throughout their career, Daly has acquired expertise in various regulatory, clinical, and quality areas, including FDA regulations, 510(k), PMA, IDE, HUD, HDE, Q-Sub, class II and III devices, QMS, QSR, MDR, vigilance, and more. Kevin E. also has experience in CE Mark, ISO 13485, MDD/MDR, ISO 14971, and other relevant standards.

Kevin E. Daly, RAC has a Bachelor of Science degree in Biology from Fairleigh Dickinson University-Metropolitan Campus. Kevin E. also completed post-graduate business courses at Rivier University and Stevens Institute of Technology. In addition to their education, Kevin E. Daly, RAC has obtained the Regulatory Affairs Certification (RAC - US) from the Regulatory Affairs Professionals Society (RAPS).