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Headhunter | Specialising in Diagnostics & Genomics | Connecting Top Talent across the Industry
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
* 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.
Seniority level
* Seniority level
Director
Employment type
* Employment type
Full-time
Job function
* Job function
Other
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