Kevin Painter Email & Phone Number

Quality Management• Established Quality Management Systems (ISO9001 and ISO13485) in start-up situations on three occasions. Harmonised quality systems across 14 locations and achieved a single multi-site certification. Introduced Six-Sigma, resulting in improvements in operational effectiveness.Regulatory Affairs (Devices)• Industry advocacy with the EU Commission during the development of the IVD Directive. Lead a compliance program across four SBUs resulting in the timely registration of over 1000 devices. Successfully transferred registrations and Notified Body approvals during a business carve-out. Twice authored chapters in the RAPS manual “Fundamentals of EU Regulatory Affairs”Enterprise Risk Management• Successfully transferred ICHQ9 Quality Risk Management principles to Quality in GCP, within an industry leading Clinical Development organization. Influential in designing and implementing an Enterprise-wide Risk Management process for an €18 Billion healthcare company.Management of change• Extensive enterprise change management experience at a senior level, including establishing a €900 million multi-country enterprise model based on SAP and a €300 million business relocation from Ireland to Switzerland. In 2010 was EU lead on a Contract Manufacturing relocation from the US to Poland.Specialties: Quality Management, Regulatory Affairs (Devices), Enterprise Risk Management, Management of change.

Listed skills include Regulatory Affairs, Iso 13485, Medical Devices, Quality Management, and 24 others.