Richard Saunders

Background

About Richard Saunders

A focussed and results driven senior manager, with extensive regulatory affairs and quality assurance experience in the in-vitro diagnostics (IVDs) and medical devices (MDs) product field. In depth knowledge and practical application of the Quality System Regulations and ISO 13485:2003 standard to the design and manufacture of IVDs and MDs. Able to utilise knowledge and understanding of the regulations to ensure that products come to market in a cost effective, timely and compliant way. A successful track record of dealing with product recalls, vigilance reporting and managing regulatory authority audits.An accomplished leader in building, coaching and developing successful teams and managing organisational change. A recognised industry authority on the labelling and standard requirements for IVDs and MDs. Interested in continuing to utilise and develop regulatory and quality experience. Specialties: European Medical Device and in-vitro diagnostics (IVD) regulations, internal and external audits, cGMP and Design Control expertise, Competent / Regulatory Authority liaison, product recalls, vigilance / medical event reporting and labelling specialist. Medical Devices, In-Vitro Diagnostics, CE, FDA, 510k, Technical Documentation, Vigilance, Document Control, Quality Systems, ISO9001, ISO13485