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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 diagnostic solutions to market.
- Qualifications: Experience in regulatory affairs, especially with FDA and EU IVDR submissions.
- Other info: Ideal for proactive leaders who thrive in dynamic settings.
The predicted salary is between 48000 - 72000 £ per year.
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 for more information.41bf1e1f-b16b-4260-a40a-17c77a06fd15
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
Familiarise yourself with the latest FDA and IVDR regulations. Understanding the nuances of these regulatory pathways will not only help you in interviews but also demonstrate your commitment to staying updated in a fast-evolving field.
✨Tip Number 2
Network with professionals in the IVD and diagnostics sectors. Attend industry conferences or webinars to connect with key players and gain insights into current trends, which can give you an edge during discussions with our team.
✨Tip Number 3
Prepare to discuss specific examples of your past regulatory successes, especially those involving FDA submissions. Being able to articulate your experience clearly will showcase your expertise and confidence in handling complex regulatory challenges.
✨Tip Number 4
Demonstrate your collaborative mindset by thinking of ways you can work effectively across functions. Be ready to share how you've influenced senior stakeholders in previous roles, as this is crucial for the leadership aspect of the position.
We think you need these skills to ace Director of Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in regulatory affairs, particularly within the IVD and diagnostics sectors. Emphasise any successful FDA submissions you've managed and your familiarity with EU IVDR requirements.
Craft a Compelling Cover Letter: In your cover letter, showcase your leadership skills and collaborative mindset. Mention specific examples of how you've influenced senior stakeholders and managed multiple regulatory projects in fast-paced environments.
Highlight Relevant Experience: Clearly outline your experience with regulatory strategy from development through to post-market compliance. If you have worked in small-to-mid-sized life sciences companies, be sure to include this as it aligns with the desirable experience for the role.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents. Check for any grammatical errors or typos, and ensure that all information is clear and concise. A polished application reflects your attention to detail.
How to prepare for a job interview at Hartmann Young
✨Showcase Your Regulatory Expertise
Be prepared to discuss your previous experience in regulatory affairs, particularly within the IVD and diagnostics sectors. Highlight specific FDA submissions you've successfully managed, such as 510(k) or Pre-Subs, and demonstrate your understanding of EU IVDR requirements.
✨Demonstrate Collaborative Skills
Since this role requires working closely with various teams, be ready to share examples of how you've effectively collaborated with R&D, Clinical, Quality, and Operations teams in the past. Emphasise your ability to influence senior stakeholders and navigate cross-functional environments.
✨Prepare for Complex Scenarios
Expect questions that assess your ability to interpret complex regulatory requirements. Prepare to explain how you would translate these into actionable strategies, perhaps by discussing a challenging project you've handled and the outcomes achieved.
✨Highlight Organisational Skills
In a fast-paced setting, managing multiple projects is crucial. Be ready to discuss your organisational strategies and tools you use to stay detail-oriented and analytical. Share specific examples of how you've prioritised tasks and met deadlines in previous roles.
