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For Companies At a Glance
- Tasks: Lead a team in ensuring regulatory compliance for innovative diagnostic products.
- Company: Join a growing diagnostics innovator with a global presence and a commitment to quality.
- Benefits: Enjoy remote work flexibility, competitive salary, and opportunities for career progression.
- Why this job: Be part of a dynamic team making a real impact in healthcare compliance and innovation.
- Qualifications: Strong knowledge of IVD regulations and experience in global markets preferred.
- Other info: This role offers genuine scope for growth as the company expands.
The predicted salary is between 60000 - 65000 £ per year.
A growing diagnostics innovator is building out its UK-based Regulatory Affairs team and looking for a Team Leader to help drive forward their global compliance efforts. With ~80 IVD products already on the market across the US, Canada, Europe, Australia, and more, the business is shifting from a split international model to a fully integrated RA function — covering pre-market, post-market, and continuous improvement activities from one central team.
About the Role
You’ll lead a small team (including RA officers and admin staff), take ownership of regulatory input into product changes and compliance activities, and play a key role in embedding structure and clarity into the team’s day-to-day operations. There’s genuine scope for progression as the business grows.
Key Responsibilities
- Coordinate and oversee regulatory input for product changes and ongoing compliance work
- Mentor and support junior team members
- Liaise with manufacturing, QA, and project leads to ensure smooth project delivery
- Support submission planning and document updates for international registrations
What We’re Looking For
- Strong working knowledge of IVD regulations (IVDD/IVDR essential)
- Exposure to global markets (FDA, Health Canada, etc. preferred)
- Proactive communicator with practical, solutions-oriented thinking
- Based within commuting distance or able to commit to regular time on-site
Salary: £60–65k (depending on experience)
Type: Permanent, full-time
Remote flexibility
Contact Detail:
CAPU Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Familiarise yourself with the latest IVD regulations, particularly IVDD and IVDR. Being well-versed in these regulations will not only boost your confidence during discussions but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with global markets like the FDA and Health Canada. Engaging with industry peers can provide valuable insights and may even lead to referrals.
✨Tip Number 3
Prepare to discuss your leadership style and how you’ve successfully mentored junior team members in the past. Highlighting your ability to support and develop others will resonate well with the hiring team.
✨Tip Number 4
Showcase your proactive communication skills by preparing examples of how you've effectively liaised with cross-functional teams in previous roles. This will illustrate your capability to ensure smooth project delivery.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience with IVD regulations and any relevant global market exposure. Use specific examples that demonstrate your knowledge and skills related to regulatory affairs.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention how your background aligns with the key responsibilities outlined in the job description, particularly your experience in coordinating regulatory input and mentoring team members.
Showcase Your Communication Skills: Since the role requires proactive communication, provide examples in your application of how you've effectively liaised with different teams or stakeholders in previous positions. This will demonstrate your ability to support smooth project delivery.
Highlight Your Leadership Experience: If you have experience leading teams or projects, make sure to include this in your application. Discuss how you've mentored junior staff and contributed to team structure and clarity, as these are key aspects of the role.
How to prepare for a job interview at CAPU Search
✨Know Your Regulations
Make sure you have a solid understanding of IVD regulations, particularly IVDD and IVDR. Be prepared to discuss how these regulations impact product changes and compliance activities, as this will show your expertise in the field.
✨Showcase Leadership Skills
As a Team Leader, you'll need to demonstrate your ability to mentor and support junior team members. Think of examples from your past experiences where you've successfully led a team or helped others grow in their roles.
✨Communicate Proactively
Highlight your communication skills during the interview. Be ready to discuss how you liaise with different departments like manufacturing and QA to ensure smooth project delivery. This will showcase your collaborative approach.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving abilities. Prepare examples of how you've handled regulatory challenges in the past, focusing on your solutions-oriented thinking and practical approaches.
