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Director of Regulatory Affairs

Hartmann Young
Cambridge
4 weeks ago
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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 for more information.

Seniority level

  • Seniority levelDirector

Employment type

  • Employment typeFull-time

Job function

  • Job functionOther

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