Attorney and executive business leader with 17 years of experience driving regulatory, compliance, and operational success within the health care, life science, food, and cosmetics industries. I provide strategic and insightful legal counsel to business executives and functional teams on manufacturing, distributing, marketing, and importing products regulated by the FDA, FTC, EPA and USDA, as well as global standards such as ISO 13485, 9001 and 14971. As an executive business leader, I skillfully balance restrictive regulatory frameworks with business needs, advising on corporate governance and risk management, as well as implementing controls to insulate companies from civil and administrative liabilities.Representative experience includes:- Global Head of Compliance & Regulatory for global manufacturer of diabetic supplies and disease management software, formerly owned by J&J.- Former VP of Regulatory Affairs, Compliance and Operations to software as a medical device (SaMD) start-up- Successfully secured pre-market clearance via 510(k) process of numerous medical devices including digital health devices, software, and surgical tools- Represented businesses importing personal protective equipment (PPE) in response to COVID 19- Counseled companies across the globe on product and label requirements for medical devices, OTC drugs, dietary supplements, conventional foods and cosmetics- Lead medical device manufacturers through ISO 13485 and MDSAP certification processes- Represented medical devices, dietary supplements, conventional foods and cosmetics in the conduct of recalls and resolution of subsequent claims from national retailers, hospitals, and consumers- Oversaw customer complaint and adverse event reporting responsibilities for companies of all sizes- Drafted, revised and negotiated service agreements, vendor/supplier contracts, business associate agreements (BAA) and other corporate contracts to achieve parties' mutual business and regulatory goals