Teams at Clinisys

Lead global regulatory affairs for diagnostic informatics and healthcare software products. Responsibilities include developing market access and lifecycle strategies, preparing regulatory submissions and registrations, assessing product changes and emerging requirements, managing compliance risks, supporting audits and inspections, and advising cross-functional teams across product, R&D, quality, clinical safety, legal, commercial, and operations. The role requires expertise in international medical device and diagnostics regulations, standards, post-market compliance, and professional use of AI-enabled tools.

Lead a portfolio of complex healthcare IT transformation programmes across the UK and Ireland, including pathology, LIMS/LIS, and Order Communications implementations. Responsibilities include executive stakeholder management, programme governance, risk and financial oversight, customer escalations, commercial support, operational improvement, AI adoption, and coaching delivery teams. The role owns programme performance, quality, budgets, profitability, and customer satisfaction while supporting digital transformation across Professional Services.

Investigate and resolve customer complaints, clinical safety issues, and product risks across diagnostic products. Manage complaint lifecycles, assess regulatory reporting obligations, conduct root cause analysis, support CAPA and post-market surveillance, maintain hazard logs, and apply risk management standards. Use data analytics and AI tools for complaint trending and signal detection, present findings to stakeholders, and maintain audit-ready quality records while supporting audits, inspections, and continuous improvement.