Medical devices RA, QA consultant• Extensive experience in implementation and maintenance of Quality Systems (MDSAP, ISO 13485:2016..)• Submissions, Registration and listing medical devices (FDA, Health Canada, CE …). • US, Canadian, EC regulatory requirements and approvals.• Excellent background and understanding in technical, R&D, and operations issues. • Risk management. Regulatory correspondent; MDR, Recall • Experienced in development, manufacturing and quality assurance large and small organizations.• FDA, Notified Bodies audit participation experience as well as Large US companies suppliers audit experience.
Listed skills include Medical Devices, Quality System, Design Control, Iso 13485, and 1 others.