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- Tasks: Lead a team in ensuring regulatory compliance for medical devices across global markets.
- Company: Join a respected leader in the medical device and IVD industry.
- Benefits: Enjoy hybrid or remote working options with a negotiable salary based on experience.
- Why this job: Make a real impact in a senior role while collaborating with a high-performing team.
- Qualifications: Extensive experience in regulatory affairs, especially with high-risk Class D devices is essential.
- Other info: Must have the right to work in the UK and excellent communication skills.
The predicted salary is between 36000 - 60000 £ per year.
Location: Central Scotland with hybrid or remote working available
Salary: Negotiable depending on experience
We are recruiting for an experienced Regulatory Affairs Department Lead to join our client, a well-established and respected name in the medical device and in vitro diagnostics (IVD) industry. This is a senior leadership role where you'll oversee a small, capable team and take responsibility for regulatory compliance across multiple global markets, including the US, Canada, and Europe. The focus is on someone who can bring real depth of experience with high-risk Class D devices, and who understands the complexities of IVDR, FDA and Health Canada regulations inside out. You'll need to be comfortable leading from the front, acting as PRRC, and steering technical documentation, submissions, and post-market activities through a constantly evolving regulatory landscape.
What you'll be doing:
- Lead and develop the Regulatory Affairs department, managing a small team
- Oversee preparation, review and maintenance of technical documentation and submissions for Class D IVD devices (IVDR, FDA 510(k)/PMA, Health Canada)
- Act as Person Responsible for Regulatory Compliance (PRRC) and ensure compliance with GMP and ISO13485
- Support post-market surveillance, vigilance and risk management processes
- Act as a key point of contact with regulatory bodies and external partners
- Work closely with other departments to align regulatory work with wider business priorities
- Maintain a regular on-site presence, with flexibility around hybrid or remote working
What you'll need:
- Extensive regulatory affairs experience within IVD or medical devices
- Proven track record with regulatory submissions for high-risk Class D devices
- Strong knowledge of IVDR, FDA and Canadian medical device regulations
- Hands-on experience of post-market compliance, risk and vigilance activities
- People management experience, with the ability to lead and mentor a team
- A collaborative approach and the confidence to work with internal stakeholders and regulatory bodies
- Fluent English and excellent communication skills
- Must already have the right to work in the UK
What next?
If you're looking for a senior role where you can make a real impact and bring your expertise to a high-performing team, we'd love to hear from you. Send your CV or contact us to find out more.
Regulatory Affairs Manager employer: Escape Recruitment Services
Contact Detail:
Escape Recruitment Services Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with Class D devices. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory compliance.
✨Tip Number 2
Familiarise yourself with the specific regulations for IVDR, FDA, and Health Canada. Consider joining relevant online forums or groups where you can discuss these regulations with peers and gain insights into best practices.
✨Tip Number 3
Prepare to demonstrate your leadership skills during interviews. Think of examples where you've successfully led a team through complex regulatory processes or mentored junior staff, as this will be crucial for the role.
✨Tip Number 4
Research the company thoroughly before your interview. Understand their product lines, market presence, and any recent news related to their regulatory affairs. This knowledge will help you tailor your responses and show your genuine interest in the position.
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 extensive regulatory affairs experience, particularly with high-risk Class D devices. Emphasise your knowledge of IVDR, FDA, and Health Canada regulations, as well as any relevant leadership experience.
Craft a Compelling Cover Letter: In your cover letter, explain why you are the ideal candidate for the Regulatory Affairs Manager role. Discuss your proven track record with regulatory submissions and your ability to lead and mentor a team. Be sure to convey your passion for the medical device industry.
Showcase Relevant Achievements: Include specific examples of your past achievements in regulatory affairs, such as successful submissions or compliance projects. Quantify your successes where possible to demonstrate your impact in previous roles.
Proofread Your Application: Before submitting your application, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Escape Recruitment Services
✨Showcase Your Regulatory Knowledge
Make sure to highlight your extensive knowledge of IVDR, FDA, and Health Canada regulations during the interview. Prepare specific examples of how you've navigated these regulations in past roles, especially with high-risk Class D devices.
✨Demonstrate Leadership Skills
As this role involves leading a team, be ready to discuss your people management experience. Share instances where you've successfully mentored team members or led projects, showcasing your ability to inspire and guide others.
✨Prepare for Technical Questions
Expect technical questions related to regulatory submissions and compliance processes. Brush up on your knowledge of preparing technical documentation and post-market activities, as these will likely be key discussion points.
✨Align with Business Priorities
Understand how regulatory affairs fit into the broader business context. Be prepared to discuss how you can align regulatory work with the company's goals and collaborate effectively with other departments.
