Dimitris Demirtzoglou, MBA | Principal Consultant, Regulatory & Quality Strategy

Dimitris Demirtzoglou is a regulatory affairs and quality executive with more than two decades of leadership experience helping organizations navigate complex global regulatory environments and bringing innovative healthcare products to market. 

As a Principal Consultant for Regulatory & Quality Strategy at The Attic Muse, he partners with medical device, diagnostics, digital health, and healthcare technology organizations to develop regulatory strategies, strengthen quality systems, and accelerate market readiness.

Throughout his career, Dimitris has held leadership roles within globally recognized organizations including Abbott, Roche Diagnostics, Sekisui Diagnostics, and Becton Dickinson (BD), while also supporting emerging startups and high-growth companies across the medical device, diagnostics, software as a medical device (SaMD), and healthcare technology sectors.

Dimitris specializes in regulatory strategy, FDA submissions, global market access, quality systems development, organizational readiness, and regulatory operations. His expertise spans Class I, II, and III medical devices, in vitro diagnostics (IVDs), software-enabled healthcare products, and international regulatory frameworks.

Over the course of his career, Dimitris has successfully led complex regulatory submissions, developed and transformed Quality Management Systems aligned with ISO 13485, ISO 9001, and related standards, and driven digital transformation initiatives that improve regulatory efficiency, strengthen compliance, and enhance organizational performance.

Known for his collaborative leadership style and practical approach to problem solving, Dimitris works closely with clients to identify strategic pathways that align business objectives with regulatory requirements. His focus is on helping organizations achieve compliance efficiently while maintaining agility, innovation, and sustainable growth.

Dimitris holds a Bachelor of Arts in Molecular Biology and Biochemistry with a Minor in Economics from Rutgers University, a Master of Business Administration (MBA) from Indiana University Indianapolis (formerly IUPUI), and a Clinical Research Certificate from Indiana University Indianapolis. 

He is a member of the Regulatory Affairs Professionals Society (RAPS), a published researcher, and maintains expertise across FDA regulations, ISO 13485, ISO 9001, ISO 27001, European regulatory frameworks, and global quality systems.

Fluent in both English and Greek, Dimitris brings a unique combination of scientific expertise, business acumen, and executive leadership experience to organizations operating within highly regulated industries.

Outside of his professional work, Dimitris enjoys exploring emerging technologies, mentoring regulatory professionals, exploring his local Costco warehose, and spending time with his family and pets.