Associate Director – Regulatory Affairs (IVD) | Cambridge

Hartmann Young is partnered with an innovative and fast-growing diagnostics company based in Cambridge. We’re seeking a proactive and experienced Associate Director of Regulatory Affairs to lead global regulatory strategy across a portfolio of pioneering IVD technologies. This is a high-impact, hands-on leadership role supporting both FDA and IVDR pathways, ideal for someone who thrives in a collaborative, cross-functional environment.

You’ll work closely with R&D, Clinical, Quality, and Operations teams to bring impactful diagnostic solutions to global markets — from early development through to registration and post-market compliance.

Key Requirements: Proven experience in regulatory affairs within the IVD, diagnostics , or medical device sectors Demonstrated success with FDA submissions (e.g., 510(k), Pre-Subs) Strong working knowledge of EU IVDR and technical documentation requirements Skilled at interpreting complex regulatory requirements and translating them into actionable strategies Confident liaison with regulatory authorities and

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