Amy Winegarden
Director, Regulatory Affairs @Avanos Medical
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WORK HISTORY
Director, Regulatory Affairs @Avanos Medical
Promoted to lead Regulatory Affairs Sustaining and Strategic Operations (RASSO)— a function at the intersection of strategy, structure, and sustainability within Global Regulatory Affairs. I oversee a cross-functional team that covers regulatory intelligence, advertising and promotion, compliance, publishing, state licensing, and regulatory systems and data management.I’m focused on building the connective tissue between regulatory strategy and operational execution — ensuring the right information, at the right time, flows through the right channels. That means smarter systems, stronger collaboration, and scalable processes that keep innovation compliant and compliant innovation moving.Core areas of accountability:>Lead a talented team spanning strategic, operational, and technical regulatory functions.>Drive modernization of regulatory systems and processes, including RIMS, labeling, and change management integration.>Champion data integrity and regulatory visibility across global portfolios.>Partner with Quality, Clinical, and International teams to align on global compliance readiness and product lifecycle management.>Develop people, processes, and tools that foster both regulatory excellence and team wellbeing.Recent focus:Standing up the Regulatory Change Management function, evolving our Regulatory Intelligence platform, and continuing to embed a culture of clarity, accountability, and continuous improvement.
EDUCATION
University of Pittsburgh
Bachelor of Arts (B.A.), Liberal Arts and Sciences, Concentration in English Communications
SKILLS
ABOUT AMY WINEGARDEN
When I was ten, I organized a neighborhood carnival for Jerry’s Kids. I sent for the kit, held committee meetings, recruited the “older kids” for game design, and rallied the parents for food and prizes. We raised real money, built community, and learned the power of planning, communication, and continuous improvement — all before middle school.That early experience shaped everything I’ve done since: build teams, clarify the mission, connect people, and make hard things easier through structure and collaboration.Today, I’m Director of Regulatory Sustaining & Strategic Operations at Avanos, where I lead a global team that spans regulatory intelligence, compliance, and more. My focus is on connecting people, process, and purpose — ensuring we deliver safe, effective, compliant products while empowering the humans behind the work.I’m a firm believer that regulatory excellence and leadership excellence go hand in hand. The same lessons from that backyard carnival still apply:Listen before leading.Educate and elevate others.Make the process better each time.Areas of focus: Regulatory systems strategy • MedTech compliance • Leadership development • Change management • Team building • FDA/MDR/global submissionsPrincipled and empathetic leadership is my anchor. Curiosity, humor, and continuous learning keep me steady — and a little chaos now and then keeps things interesting.
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