A former practicing attorney with over 30 years working in regulated industries applying well-developed critical thinking, concise communication, and organizational skills to understand complex information and provide solutions in a highly collaborative manner. Exceptional manager of direct reports and cross-functional colleagues to drive process improvement through integrity, trust, and transparent communication.Career Accomplishments and Successes• Over a 4-year period, initiated, planned, and led the corporate-wide project for the integration of the European Medical Device Regulation quality system and device conformity requirements resulting in CE Marking of a Class III endovascular stent graft and delivery system used for the treatment of Abdominal Aortic Aneurysms.• Founded, planned, and managed for 6 years a Regulatory Operations group to perform administrative and compliance processes for submission publishing, global regulatory approvals, U.S. device tracking and UDI, external standards, recalls and field safety notices, advertising and promotional materials, and department financial affairs. Acted as the front-room subject matter expert in FDA annual and Notified Body recertification audits for these processes.• Led cross-functional process improvement initiatives and CAPA investigation for approved device shipping authorization, device tracking, UDI registration, and external standards review.• Following an investigation of company promotional material development and publishing practices, co-led with the company Compliance officer and legal counsel the overhaul of the promotion material review process to establish accountable roles and responsibilities, more stringent review standards, and regular oversight meetings to provide greater visibility of activities to mid-level management and an escalation process to senior leadership for critical issues with regulatory impact.• Led sales and operations activities for a contract medical device sterilization services company for over 3 years. Expanded the company into disinfection and precision cleaning services for medical device reprocessing.• Led business development activities for a high-margin aerospace precision cleaning services, doubling revenue year-over-year for 3 consecutive years.• Published and presented approximately 10 peer-reviewed articles on contamination control technologies for precision fluid system components in automotive, construction, and transportation fuel, lubrication, and hydraulic systems.