IVDR Regulatory Strategy Lead – Remote/Europe

Parexel is seeking an experienced Regulatory Affairs professional to lead IVD regulatory strategy across EU markets. You will drive performance evaluation study strategies, manage technical documentation, coordinate global submissions with cross-functional teams, and guide project teams through EU IVDR, ISO 13485, and ISO 20916 requirements to enable timely approvals. The role can be home or office based across Europe, allowing interactions with health authorities and notified bodies to ensure …