Derek Mclean
Head Of Quality and Regulatory Affairs
Quality Assurance
Insulet
United Kingdom
Biography
Executive Management Key member of the European Executive Management team responsible for the build and delivery of strategic roadmap initiatives across the EMEA region including: The build of an EMEA team covering Sales, Marketing and Operations. The design and approval of Marketing collateral. The selection and on-going management of distributors. KOL engagement and Ad-board meeting participation. Prioritisation and participation of key medical and scientific events in Europe The development of country specific strategic programs Forecast and budget control. • Operations, Quality Assurance and Regulatory Affairs Established and managed warehousing and logistics solutions to support EMEA business. Key supplier selection and management including sub-manufacturing, lab equipment procurement Built Quality system to support EMEA business in Middle East Responsible for CE marking and all in-country product registrations for the Cologuard Colorectal Screening product. Served as European Authorised Representative Established Adverse Event reporting process for the region. Laboratory management training and support Established and implemented partner lab agreements Responsible for partner lab installations, training of lab personnel and telephone /on-site support. Successfully delivered project to design, implement and commission an Exact Sciences owned lab in the UAE
Research Interest
quality assurance medical devices
