Consultant – RWE Project Manager, Medical Devices

Responsibilities

• Lead and coordinate PMCF (Post-Market Clinical Follow-up) data collection
• Design and implement simple post-market clinical studies
• Draft study protocols, case report forms (CRFs), and final clinical study reports
• Ensure collected data comply with the MDR (EU Medical Device Regulation 2017/745) requirements
• Provide methodological support to investigator physicians
• Manage timelines, monitor enrollments, and liaise with hospitals and clinical sites
• Lead regulatory activities and necessary submissions

Requirements

• Minimum 4 years of clinical project management experience, ideally in the medical devices sector
• Strong understanding of PMCF requirements under the EU Medical Device Regulation (MDR)
• Ability to collaborate with domain experts and provide methodological support
• Fluent English (for international contexts and scientific writing)