Legal And Regulatory Compliance Manager
Chicago, Illinois, United States
● Developed strategies for business development, marketing opportunities, and risk management to c-suite executives resulting in company growth from 5 to 52 people and expansion from the U.S. into EU medical device markets● Conducted value-based pricing analysis and sales strategy for innovative healthcare technologies, resulting in +411.8% increase in profit per unit sold and down-regulation of FDA marketing requirements● Directed intellectual property and patent design strategy resulting in 8 novel patents for company flagship products● Designed clinical research protocols to align with company objectives, budget, timeline, and go-to-market strategy● Spearheaded cross-functional leadership meetings to determine FDA regulatory risk in AI/ML products, resulting in 4 successful FDA submissions and continued compliance with GMP and Quality Records protocols for class II devices● Composed contracts and proposals, including: partnership, license, sales, terms of use, disclosure, and collaboration agreements with universities, hospitals, privately-owned and publicly-owned companies● Advised early-stage medical device start-up companies through initial phases and funding to increase revenue from $0 to $470,000 within 3 months● Designed and integrated regulatory and quality training to increase company-wide compliance from 87% to 100% for existing and on-boarding employees
