FSP - Regulatory Affairs Consultant CMC Medical Devices (EU/UK location)

We are looking for a Regulatory Affairs professionals to join us and take up a client dedicated 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.

• Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of devices (standalone and in all types of drug-device combination) to expedite the submission, review and approval of global CMC applications.

• Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy for devices.

• Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.

• Ensures regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.

• Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency) and potentially  external advocacy and shaping the regulatory environment). 

• Will sometimes deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial support.

Skills and Experience required for the role:

• University degree in a Life Science or related scientific discipline

• Device regulatory affairs or device (standalone and in all types of drug-device combinations) development and manufacturing experience with direct involvement in regulatory submission preparation for devices.

• Sound knowledge of device development, manufacturing processes and supply chain.

• Knowledge of worldwide CMC regulatory requirements for devices and successful track record of delivering dossiers that comply with these

• Development experience ideally including previous roles within product development.

• Demonstrated ability to handle global CMC issues related to devices through continuous change and improvement.

• Strong interpersonal, presentation and communication skills with established internal networks.

• Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines. 

• Fluency in English