Mark Moynihan is a QA/RA Director based in Ireland with over 13 years’ experience in the medical device industry, specialising in regulatory compliance and quality systems across a range of device types, including orthopaedic implants, surgical instruments, software, and electronic medical devices. He is responsible for establishing and maintaining Quality Management Systems in line with ISO 13485, EU MDR 2017/745, and US FDA 21 CFR 820 (QMSR), and acts as Person Responsible for Regulatory Compliance (PRRC) under the MDR. Mark leads global regulatory strategies supporting product approval and lifecycle management.

He joined OrthoXel in 2019, having previously held senior QA/RA roles within another medical device start-up. Mark holds a BSc in Microbiology, an MSc in Bioinformatics & Systems Biology, and an MBA, and has completed specialist training in medical device regulation and quality systems.