At a Glance
- Tasks: Lead a team in ensuring regulatory compliance for innovative diagnostics products.
- Company: Join a growing diagnostics innovator with a global presence and exciting product range.
- Benefits: Enjoy remote work flexibility and opportunities for career progression.
- Other info: Position based in Edinburgh with occasional site visits required.
- Why this job: Be part of a dynamic team making a real impact in healthcare compliance.
- Qualifications: Strong knowledge of IVD regulations and experience in global markets preferred.
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
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager in Dartford
✨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 staying updated in this fast-evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience with global markets like the FDA and Health Canada. Engaging in conversations 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 would mentor junior team members. Highlighting your experience in leading teams and fostering a collaborative environment will resonate well with the hiring managers.
✨Tip Number 4
Showcase your proactive communication skills by preparing examples of how you've successfully liaised with cross-functional teams in the past. This will illustrate your ability to ensure smooth project delivery and compliance.
We think you need these skills to ace Regulatory Affairs Manager in Dartford
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 regulatory knowledge and leadership skills.
Craft a Compelling Cover Letter:In your cover letter, express your enthusiasm for the role and the company. Discuss how your background aligns with the key responsibilities mentioned 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, include examples in your application that illustrate your ability to liaise effectively with different teams, such as manufacturing and QA, to ensure project success.
Highlight Continuous Improvement Experience:Mention any past experiences where you contributed to continuous improvement activities within a regulatory framework. This will show your understanding of the importance of compliance and your ability to drive enhancements in processes.
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
Since the role requires liaising with various departments, practice articulating your thoughts clearly and concisely. Prepare to discuss how you would handle communication challenges and ensure smooth project delivery.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills and solutions-oriented thinking. Prepare scenarios where you had to navigate regulatory challenges or improve compliance processes, and be ready to explain your thought process.
