Job Description

ABOUT THIS ROLEWe are looking for a Regulatory Affairs professionals to join us and take up a role within CMC Medical Devices. The role can be based in various locations in Europe, home or office based.In this role you will be responsible for supporting the CMC regulatory activities relating to development, registration and manufacturing of devices (standalone and in all types of drug-device combinations). You may act as a CMC Regulatory expert in a specific subject area.Key Responsibilities:Responsible for the global CMC regulatory activities associated with devices for assigned projects and respond readily to changing events and priorities.Responsible for CMC strategy development (with managerial support) and creation of CMC submission documents for devices from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and commercial lifecycle management activities in accordance with the applicable regulatory & scientific standards.