Gwendolyn Pinto

Gwendolyn Pinto is an experienced Regulatory Affairs & Quality Assurance leader with more than 10 years’ experience in Medical Devices. As Director, RA & QA at Exact Imaging, Gwendolyn is responsible for global markets registration of Exact Imaging product lines, implementing continuous improvement opportunities to ensure compliance to national and global regulations and maintaining an effective quality management system.

Prior to joining Exact Imaging, Gwendolyn managed a cross-functional team at Laborie Medical Technologies Canada ULC. as a Regulatory Affairs Manager of Global Emerging Markets where she was responsible for the creation and management of global regulatory submissions to support product registration activities for Laborie and its acquisition companies in emerging global markets in Asia, Latin America, Middle East, Eurasia & Oceania, in addition to Canadian, USA & European markets.

During her time at Laborie, Gwendolyn spearheaded and closed out numerous quality management system projects, CAPAs, complaint handling and other supplier-related project management activities. She was the audit lead on many global regulatory body site audits from the FDA, Health Canada, ANVISA (Brazil), Japan, S. Korea and addressed responses to various Notified Body Technical File Audit assessments for Europe CE Mark. As the regulatory subject matter expert, Gwendolyn contributed to design & development, labeling, risk management, usability and clinical requirements for various new design projects and sustaining product design change control processes.

Gwendolyn is a certified internal auditor with hands-on expertise in leading companies to achieve compliance to the ISO 13485:2016, 21 CFR 820, MDD 93/42/EEC, EU MDR 2017/745 & MDSAP regulations.

Gwendolyn holds a Master of Science (MSc.) in Regulatory Affairs for Drugs, Biologics and Medical Devices from Northeastern University in Boston, MA and a Bachelor of Science (BSc.) in Neuroscience and Health Studies from the University of Toronto.