Kira Smith Email and Phone Number

A multi-skilled scientist with over 13 years experience in the medical device (IVD) industry - 5 years experience within a laboratory and a following 8+ years in quality assurance and regulatory affairs. I currently work for a company which develops and manufactures in vitro diagnostic kits for the detection and measurement of autoantibodies in a variety of autoimmune diseases with our key areas being thyroid autoimmunity and type 1 diabetes. As part of my current regulatory position, I have a working knowledge of EU directive 98/79/EC, with a current focus on preparing for the new IVDR 2017/746.One of my main roles includes compiling and maintaining technical files for our diagnostic kits as well as CE marking and registration of kits with the MHRA. I also work with clients preparing data and regulatory documents for submissions to global regulatory bodies such as the US FDA, Chinese FDA and MHLW.I am also involved with the quality assurance side the business, maintaining the QMS, writing SOPs, carrying out internal audits in line with ISO 9001 and ISO13485 and implementing CAPAs.Also a skilled laboratory scientist with hands on experience in, SDS-PAGE, Reverse Transcription Polymerase Chain Reaction (RT-PCR), and working with ionising radiation, in particular 125-iodine.