Providing guidance and support for development and approval of medical device technologies worldwide.

•Submissions of combination products in complex regions including Shonin approval in Japan, conformity assessment certification in Australia, Canadian medical device license as well as emerging markets such as South Korea and Taiwan.•Preparation and submission of a drug eluting stent IDE application, subsequent amendments and supplements as well as preparation for PMA submission. •Provision of regulatory input as a team member for new development projects, product life cycle maintenance and product changes.•Manufacturing, quality and process related projects.•Review and feedback on technical reports and validation data analysis.•Contribution to risk analysis and failure mode and root cause analysis.•Review of marketing material, IFU and labeling compilation, participation in customer and supplier visits, contribution to inter-departmental meetings, review of relevant submission documentation, dossier creation and maintenance.

Specialist for combination products for both new and mature devices. Experienced with CTD maintenance, change management activities and production and development support. Involvement in CE, ROW and FDA project work and country registrations in particular South Korea, Taiwan, Japan.

Along with my primary responsibilities for all FDA submission and CE marking activities, I am now focusing on departmental process improvements and project management assignments. I am the sole delegate for my manager and have become heavily involved in cross functional development including risk analysis, auditing, training and customer interfacing.

I have three years regulatory experience in a rapid growth medical device company. I have gained strong multi-functional experience within the fields of regulatory and quality compliance, clinical research, product registration and post market surveillance.

This project involved an experimental investigation into the damage to porcine coronary arterial tissue due to stress. Both the tensile and fatigue properties of the tissue were investigated with the view to establishing whether the cyclical fatigue due to the continuous presence of a stent contributed to restenosis.Technical expertise: Development of mechanical testing models for both tensile and fatigue tests, specialised rig and clamp design, extensive use of the MTS Tytron 250 micro-force machine, Zwick static testing machine, toolmakers microscope, scanco micro-ct scanner, C.C.D camera. Critical analysis of data. Methodical and organised approach to study design. Biological tissue storage, transport and tissue harvesting, sample preparation and preservation, present at various stenting procedures at St James Hospital Dublin.