Global Clinical Evaluation Lead

Job Description Posted Friday 1 May 2026 at 00:00 Global Clinical Evaluation Lead Location: Cirencester / Hybrid About the Role We are seeking an experienced Global Clinical Evaluation Lead to oversee the development and maintenance of clinical evaluation and post‑market clinical documentation across our global medical device portfolio. This is a pivotal role supporting regulatory compliance under EU MDR , global market access, and post‑market surveillance activities. The Global Clinical Evaluation Lead will be responsible for driving high‑quality Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), PMCF Plans and Reports, SSCPs , and associated literature activities, while coordinating a wide network of internal and external stakeholders. The role works closely with Product Core Teams (PCTs), clinical study teams, regulatory partners, and notified bodies, and acts as a key clinical subject‑matter expert across the business. What you’ll do Lead and oversee the preparation, review, and finalisation of clinical evaluations and associated documentation in compliance with EU MDR requirements Manage and collaborate closely with external clinical evaluation partners, including training, regular governance meetings, and timeline management Prepare and coordinate responses to clinical review questions from Notified Bodies to support product submissions and certifications Review and approve MDR deliverables including: Clinical Evaluation Plans and Reports PMCF Plans and PMCF Evaluation Reports Literature searches and critical appraisals Summary of Safety and Clinical Performance (SSCP) Contribute to global post‑market and reimbursement‑related activities across multiple markets, including EU, USA, Australia, Japan , and other international regions Act as the clinical representative at annual Post‑Market Surveillance (PMS) meetings, providing expert input into PMS plans, PSURs, and benefit‑risk assessments Participate in Product Core Team (PCT) meetings, advising on pre‑ and post‑market clinical strategy and regulatory requirements for new product registrations and renewals Work closely with data management and clinical study teams to ensure timely delivery of clinical data inputs, escalating risks to timelines where necessary Support interpretation and reporting of clinical investigation results (pre‑ and post‑market) for regulatory submissions and internal decision‑making Serve as a clinical SME to internal teams including R