Director of Regulatory Affairs
20 hours ago
Cambridge
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 notified bodies, • Collaborative mindset, comfortable working across functions and influencing senior stakeholders, • Able to manage multiple regulatory projects and priorities in a fast-paced setting, • Detail-oriented, analytical, and highly organised Desirable Experience: • Leadership of regulatory strategy from development through post-market, • Experience working in small-to-mid-sized or scaling life sciences companies, • Familiarity with companion diagnostics, point-of-care, or molecular platforms Location: Cambridge (Hybrid – 3 days/week in-office) - REQUIRED Please apply directly or reach out to for more information.