Job Description 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
✅ ...