🚨 We're Hiring: Regulatory Affairs Division Leader – Diagnostics | Edinburgh (Hybrid) 🚨
A global diagnostics innovator is entering a major growth phase, and we’re searching for a proven Regulatory Affairs Leader to steer them through it.
💡 Backed by significant investment and driving into the US market with FDA submissions, this company is scaling up fast, launching new products, expanding manufacturing, and assembling a US commercial team.
Your Mission:
Lead the regulatory function across global markets, oversee compliance, and drive strategy. You’ll be the go-to expert guiding the business through complex regulatory landscapes, from ISO13485 to FDA and IVDR.
What You’ll Be Doing:
* Owning global RA strategy and leading from the front
* Overseeing regulatory submissions: CE marking (IVDD/IVDR), FDA, Health Canada
* Ensuring company-wide compliance and audit readiness
* Leading your team and partnering with senior cross-functional stakeholders
* Contributing to quality initiatives and post-market surveillance
* Navigating evolving international legislation and regulatory requirements
What You’ll Bring:
✅ Experience in diagnostics or medical device manufacturing
✅ Strong track record with FDA, CE marking, IVDR, and ISO13485
✅ Leadership and strategic influence in regulatory functions
✅ A sharp, decisive, and collaborative mindset
Why Join?
🌍 Global impact, major growth runway
🧪 State-of-the-art facilities in Edinburgh
🤝 Collaborative, people-first culture with regular team incentives
📈 Opportunities for international secondments and long-term progression