Andrew Gibson

WORK HISTORY

EDUCATION

ABOUT ANDREW GIBSON

Extensive experience in medical device regulatory affairs and quality, including a PhD in biotechnology.• Regulatory affairs – developing regulatory compliance strategies, maintaining technical files and preparing regulatory submissions for Europe, U.S. and Canadian and global markets • Clinical affairs – Clinical strategy development, clinical writing, CEP/CER, PMSR/PSUR, PMCFP/PMCFR and ISO 14155 gap analysis• Regulatory reporting – assessing complaints, communicating directly with notified bodies/competent authorities and preparing summary or trend reports• Good Manufacturing Practice – 7 years in a production lab environment with experience in all aspects of safety, quality assurance and regulatory requirements including: GDP, GLP and GMP methods/documentation• Microbiology skills including aseptic technique, media prep, plating streaking and bacterial confirmation testing• Inorganics testing including reagent preparation and sample processing for phosphorous and ammonia• Research experience – literature search, publishing, presenting research findings.