Director of Regulatory Affairs

Associate Director – Regulatory Affairs (IVD) | CambridgeHartmann 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 sectorsDemonstrated success with FDA submissions (e.g., 510(k), Pre-Subs)Strong working knowledge of EU IVDR and technical documentation requirementsSkilled at interpreting complex regulatory requirements and translating them into actionable strategiesConfident liaison with regulatory authorities and notified bodiesCollaborative mindset, comfortable working across functions and influencing senior stakeholdersAble to manage multiple regulatory projects and priorities in a fast-paced settingDetail-oriented, analytical, and highly organisedDesirable Experience:Leadership of regulatory strategy from development through post-marketExperience working in small-to-mid-sized or scaling life sciences companiesFamiliarity with companion diagnostics, point-of-care, or molecular platformsLocation: Cambridge (Hybrid – 3 days/week in-office) - REQUIREDPlease apply directly or reach out to for more information.

Created: 2025-08-03