Our client are searching for a technical QA/RA Design Specialist to join their team on a permanent basis. The role will focus on owning the technical file process including leading relevant updates based on MDR, maintaining documentation history and controlling suppliers of technical file activities. Additional activities will include: Providing international regulatory support throughout the product life cycle. Presenting and defending technical documentation during regulatory inspections. Complaint handling and root cause investigations. Handling risk assessments along with project/change management.