Caroline Sugiura
About Caroline Sugiura
Caroline Sugiura is the Senior Regulatory Affairs and Quality Manager at Boston Scientific, with extensive experience in quality management and regulatory compliance in the medical device industry.
Current Role at Boston Scientific
Caroline Sugiura currently serves as the Senior Regulatory Affairs and Quality Manager at Boston Scientific. She has held this position since 2015. In this role, she is responsible for overseeing regulatory compliance and ensuring the quality of medical devices. Her work involves facilitating regulatory audits and maintaining adherence to both local and international standards.
Previous Experience at Boston Scientific
Before assuming her current role, Caroline Sugiura worked as Quality Manager at Boston Scientific from 2011 to 2015 in São Paulo, Brazil. Prior to that, she served as a Quality Coordinator within the same company from 2008 to 2011. In these roles, she focused on maintaining quality assurance practices and managing compliance with regulatory requirements.
Professional Background at Novo Nordisk
Caroline Sugiura's professional journey includes significant experience at Novo Nordisk. She worked as an International Quality Coordinator in Denmark in 2007 for 11 months. Additionally, she served as a Quality Assurance Coordinator from 2004 to 2008 in São Paulo, Brazil. Her responsibilities included ensuring quality standards and supporting regulatory processes for pharmaceutical products.
Educational Background
Caroline Sugiura completed her studies in Pharmacy and Biochemistry at the Universidade de São Paulo. This academic foundation has supported her extensive career in quality management and regulatory affairs, providing her with the necessary expertise to navigate complex compliance and quality assurance landscapes.
Certifications and Achievements
Throughout her career, Caroline Sugiura has achieved significant certifications, including ANVISA GMP, INMETRO, and ANATEL certifications for medical devices. She has also served as a Management Representative for ISO 13485, focusing on quality management systems. Additionally, she became a Certified Scrum Master in July 2021, applying agile methodologies to enhance regulatory and quality management processes.