Dr. O’Sullivan is an experienced quality assurance and regulatory affairs professional with more than 12 years within the medical device arena. Aisling holds an honours degree in Biotechnology from Dublin City University as well as a PhD in Microbial Genetics from University College Cork.
Initially, Aisling worked in the pharmaceutical industry as a microbiologist, but moved into the medical devices area in 2005. Working as a Notified Body Auditor, with the NSAI for seven years, Aisling has gained a wealth of knowledge in both product compliance and quality systems assessments. Within NSAI, Aisling led the design dossier review of drug device combination products, implantable devices, products incorporating human blood derivatives and tissue of animal origin, as well as in-vitro diagnostic devices. As an IRCA qualified lead auditor, Aisling was the lead auditor of on-site audits for many sites including those which manufactured drug device combination products, implantable devices, products incorporating human blood derivatives and tissue of animal origin, as well as in-vitro diagnostic devices.
Since her time with NSAI Aisling has worked with orthopaedic start-up companies. Within these companies she has been responsible for all regulatory and quality aspects applicable from product design through to regulatory approval and product launch. Additionally, Aisling has demonstrated her knowledge of ISO 13485 by successfully implementing and managing ISO 13485 quality systems within start-up companies.