Regulatory Affairs Manager
Regulatory Affairs Manager

Regulatory Affairs Manager

Full-Time 60000 - 65000 £ / year (est.) No home office possible
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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 exciting future.
  • Benefits: Enjoy remote work flexibility and a competitive salary of £60–65k.
  • Why this job: Be part of a dynamic team driving global compliance and product innovation.
  • Qualifications: Strong knowledge of IVD regulations and experience in global markets preferred.
  • Other info: Opportunity for career progression 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

Regulatory Affairs Manager employer: CAPU Search

As a leading diagnostics innovator, we pride ourselves on fostering a collaborative and dynamic work environment in the Edinburgh area, where our Regulatory Affairs team plays a crucial role in ensuring global compliance for our extensive range of IVD products. We offer competitive salaries, remote flexibility, and significant opportunities for professional growth, making us an excellent employer for those looking to make a meaningful impact in the healthcare sector while enjoying a supportive culture that values innovation and teamwork.
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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 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

Strong knowledge of IVD regulations (IVDD/IVDR)
Experience with global regulatory submissions (FDA, Health Canada, etc.)
Leadership and team management skills
Proactive communication skills
Solutions-oriented thinking
Project management skills
Ability to mentor and support junior team members
Attention to detail
Understanding of compliance activities
Experience in coordinating cross-functional teams
Document management and submission planning
Adaptability to changing regulations
Strong organisational skills

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 leadership skills and regulatory knowledge.

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 quality assurance in the IVD sector.

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.

Regulatory Affairs Manager
CAPU Search
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