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- Tasks: Lead global regulatory strategy for innovative diagnostic technologies.
- Company: Join a fast-growing diagnostics company based in Cambridge.
- Benefits: Enjoy a hybrid work model and collaborative team environment.
- Why this job: Make a real impact in healthcare by bringing solutions to market.
- Qualifications: Experience in regulatory affairs, especially with FDA and EU IVDR.
- Other info: Work closely with R&D, Clinical, Quality, and Operations teams.
The predicted salary is between 60000 - 84000 £ per year.
1 week ago Be among the first 25 applicants
Direct message the job poster from Hartmann Young
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
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Seniority level
Director
Employment type
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Employment type
Full-time
Job function
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Job function
Other
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Director of Regulatory Affairs employer: Hartmann Young
Contact Detail:
Hartmann Young Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director of Regulatory Affairs
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with IVD technologies. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the sector.
✨Tip Number 2
Familiarise yourself with the specific regulatory pathways for FDA submissions and EU IVDR requirements. Understanding these processes in depth will not only boost your confidence but also demonstrate your commitment to the role during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences in leading regulatory strategies and managing cross-functional teams. Highlight specific projects where you successfully navigated complex regulatory environments, as this will showcase your hands-on leadership skills.
✨Tip Number 4
Research the company’s portfolio of IVD technologies and their market presence. Being knowledgeable about their products and how they align with regulatory requirements will help you articulate how you can contribute to their success during the interview process.
We think you need these skills to ace Director of Regulatory Affairs
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Associate Director of Regulatory Affairs position. Tailor your application to highlight your relevant experience in regulatory affairs, particularly within IVD and diagnostics.
Highlight Relevant Experience: In your CV and cover letter, emphasise your proven experience with FDA submissions and your knowledge of EU IVDR. Use specific examples to demonstrate how you've successfully navigated regulatory pathways in previous roles.
Showcase Leadership Skills: Since this is a leadership role, be sure to illustrate your ability to manage multiple projects and influence senior stakeholders. Provide examples of how you've led regulatory strategies from development through to post-market compliance.
Tailor Your Application: Customise your application materials to reflect the collaborative mindset and detail-oriented approach that the company values. Mention your experience working in cross-functional teams and how you can contribute to their innovative environment.
How to prepare for a job interview at Hartmann Young
✨Showcase Your Regulatory Expertise
Be prepared to discuss your specific experiences with FDA submissions and EU IVDR requirements. Highlight any successful projects you've led in the IVD or diagnostics sectors, as this will demonstrate your capability to handle the responsibilities of the role.
✨Demonstrate Collaborative Skills
Since the role requires working closely with various teams, share examples of how you've successfully collaborated with R&D, Clinical, Quality, and Operations teams in the past. This will show that you can thrive in a cross-functional environment.
✨Prepare for Complex Scenarios
Expect questions that assess your ability to interpret complex regulatory requirements. Prepare to explain how you've translated these into actionable strategies in previous roles, showcasing your analytical and detail-oriented mindset.
✨Engage with Regulatory Authorities
Be ready to discuss your experience liaising with regulatory authorities and notified bodies. Share specific instances where your communication skills made a difference in navigating regulatory challenges, as this is crucial for the position.
