Ann Cramer

Background

About Ann Cramer

I’m a strategic operations and delivery leader with 25+ years of experience driving transformation across medical device, pharmaceutical, and regulated technology environments. My work lives at the intersection of compliance, innovation, and execution — and I thrive when solving complex challenges that require both visionary leadership and operational discipline. Most recently, I’ve led digital product operations and portfolio delivery for Class II and SaMD solutions, transforming end-to-end delivery models to align with evolving business goals, global compliance standards (ISO 13485, HIPAA, GDPR, IVDR), and patient-centered innovation. In addition to my core leadership in product delivery and compliance, I bring a forward-looking perspective shaped by emerging themes in healthcare innovation. I’ve supported digital maturity initiatives that streamline global labeling and resource planning, creating the foundation for future AI-enabled systems. I prioritize data-driven decisions and have led cost-saving programs. My leadership emphasizes not only operational success but also team development, cross-enterprise collaboration, and a commitment to patient-centric innovation in connected health. I understand the growing importance of cybersecurity, privacy, and regulatory resilience—and I know how to scale them alongside transformation. I bring: Deep knowledge of regulatory frameworks and labeling operations Experience managing $70M+ portfolios with <5% variance Leadership of agile transformations spanning governance, finance, and engineering Proven results in global resource strategy, cost control, and stakeholder alignment Board-facing experience aligning risk, compliance, and digital health growth If you’re building the future of digital health or regulated innovation and looking for executive leadership that knows how to scale responsibly, let’s connect.