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 jamie.cross@hartmannyoung.com for more information.