Eileen Bailey Email & Phone Number

FREEHOLD Surgical, Inc., New Hope, PA 2013 - presentVP Regulatory and Quality Assurance (2013 – present)Responsible for providing regulatory, quality and technical support for the development and commercialization of Class I/II medical devices. • Implemented Quality Management System,• Provide Project Management, Quality and Regulatory support for all phases of development, product launch and post product surveillance,• Provide technical support for validation and verification activities,• Responsible for qualification, auditing and management of vendors,• Responsible for Complaint Handling and Adverse Event Reporting,• Management Representative as required by ISO13485 and be key FDA contact.

Responsible for overall project management, ensuring product development and clinical activities are carried out in compliance with FDA, cGMP regulations, ICH guidelines and ISO industry standards. Coordinate activities among manufacturing vendors, testing labs, regulatory and clinical trial partners. Prepared documentation and lead efforts for successful submission, initiation, and completion of SABRE clinical trial for class III, combination device (DEB) for the treatment of coronary ISR. Prepared documentation and coordinated submission efforts which lead to approval by FDA for IDE trial for SABRE next generation coronary device. Responsible for providing regulatory, quality and technical support for Caliber Therapeutic’s combination medical devices. • Designed, Implemented and Manage Quality Management System (QMS),• Prepared Technical File and Design Dossier for combination medical device for coronary ISR (DEB),• Lead multifunctional team responsible for SABRE (FIH) EU clinical trial for class III combination device and FDA approved IDE trial.• Lead multifunctional team in development of next generation combination device for both coronary and peripheral applications,• Liaison between CRO and Core Lab functions, • Responsible for qualification and auditing of vendors,• Defined and maintain overall project plan and budget.

Project Manager NPD/Technology – Coordinated and compiled information from customers “surgeons”, marketing, and IP associates to define product concepts, investigate IP landscape and quantify market opportunities. Expanded technology and development capabilities as needed by identifying external and internal vendors, and by partnering with them to develop new materials or processes. • Led cross functional and cross divisional engineering teams through early design control efforts, including defining design inputs and outputs, generating prototypes, conducting FMEAs and coordinating animal studies. • Responsible for defining project plan, project timeline definition and adherence, and providing technical reviews. • Created validation master plans and coordinated alternative exploration efforts focused on reducing risk and minimizing cost.• Developed four new products for GSP business unit. Products were designed for continuous manufacturing to minimize costs and maximize quality and yield. • Developed new lubricious catheter coating process to improve “ease of use”. Currently used on multiple commercial catheter devices. • Validated a medical textile manufacturer as supplier for new synthetic knit products. • Generated model for evaluating strength requirements for hernia patch products based on anatomical conditions and finite element analysis (FEA).• Led technology project to elucidate the impact of material structure and chemistry on the formation and sustainability of bio-films.

Newark, Delaware, Us

Management Review Board (Quality Assurance) – Reviewed quality system documentation to insure accuracy, completeness, and compliance with FDA design control, cGMP regulations, and industry standards (ISO13485, ISO14971). Quality documentation scope included new product development, transfer of processes/products and non-compliance issues for General Surgical Products (GSP) and Catheter Devices.

Ms, Polymer Engineering

Bs, Materials Engineering