Director of Regulatory Affairs

Hartmann Young; Cambridge; On-site; GBP 80,000 - 100,000; Full time

Job summary

A renowned recruitment agency is seeking an experienced Associate Director of Regulatory Affairs to join a fast-growing diagnostics company in Cambridge. In this leadership role, you will be responsible for leading global regulatory strategy for IVD technologies, ensuring compliance and working collaboratively with various teams. The ideal candidate has substantial IVD experience and a proven track record of FDA submissions.

Qualifications

• 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.

Responsibilities

• Lead global regulatory strategy across a portfolio of pioneering IVD technologies.
• Work with R&D, Clinical, Quality, and Operations teams to register diagnostic solutions.
• Manage multiple regulatory projects in a fast-paced setting.

Skills

Regulatory affairs experience

FDA submissions success

EU IVDR knowledge

Interpreting regulatory requirements

Liaison with regulatory authorities

Collaborative mindset

Project management in regulatory settings

Detail-oriented and analytical skills

Leadership of regulatory strategy

Experience in life sciences companies

Job description

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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 [e-mail] for more information.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

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