At a Glance
- Tasks: Lead global regulatory strategy for innovative AI medical devices and ensure compliance.
- Company: Fast-growing digital health company transforming healthcare with real-world impact.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Why this job: Shape the future of healthcare technology while leading a dynamic team.
- Qualifications: Strong background in regulatory affairs for SaMD and experience in fast-paced environments.
- Other info: Join a passionate team making a difference in healthcare innovation.
The predicted salary is between 72000 - 108000 £ per year.
A high-growth healthcare Digital Health company with large-scale real-world deployments across the UK and US is hiring a Head of Regulatory to lead global regulatory and quality strategy.
The Role
You’ll own the global regulatory roadmap across UK, EU, US and emerging markets, combining strategic leadership with hands-on execution. You’ll lead a small, high-impact team while working closely with product, engineering, clinical, and commercial leadership.
Key Responsibilities
- Lead global medical device regulatory strategy for SaMD / AIaMD
- Navigate evolving and emerging AI regulatory frameworks
- Partner with product and engineering teams to embed compliance into design and delivery
- Own relationships with regulators, auditors, and notified bodies
- Lead information security strategy as the business scales
- Manage and develop a specialist Compliance & Regulatory team
Essential Experience
- Strong background in SaMD / AI medical device regulatory affairs
- Experience operating in ambiguous or fast-evolving regulatory environments
- Able to work strategically and hands-on in a high-growth setting
- Proven cross-functional leadership with product and engineering teams
- Startup or scale-up experience
Interested or know someone suitable? Apply directly or message for a confidential discussion.
Head of Regulatory Affairs in Bristol employer: GxPeople Global
Contact Detail:
GxPeople Global Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Regulatory Affairs in Bristol
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already working in regulatory affairs. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Showcase your expertise! When you get the chance to speak with potential employers, highlight your experience with SaMD and AI regulatory frameworks. Make it clear how your background aligns with their needs.
✨Tip Number 3
Be proactive! If you see a company you're interested in, don’t wait for them to post a job. Reach out directly through our website and express your interest in regulatory roles. You never know what opportunities might be available!
✨Tip Number 4
Prepare for interviews by brushing up on current regulatory trends. Being able to discuss the latest in AI regulations will show you're not just knowledgeable but also passionate about the field. It’s all about making a lasting impression!
We think you need these skills to ace Head of Regulatory Affairs in Bristol
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Head of Regulatory Affairs role. Highlight your experience in SaMD and AI regulatory affairs, and don’t forget to showcase your leadership skills and cross-functional teamwork.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention specific experiences that align with the job description and show us your passion for regulatory affairs in the digital health space.
Showcase Your Strategic Thinking: In your application, demonstrate your ability to navigate complex regulatory environments. Share examples of how you've successfully led regulatory strategies in the past, especially in fast-paced settings like startups or scale-ups.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
How to prepare for a job interview at GxPeople Global
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations surrounding SaMD and AI medical devices. Familiarise yourself with the specific frameworks in the UK, EU, and US, as well as any emerging trends. This will show that you're not just knowledgeable but also proactive about staying updated.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams in previous roles, especially in high-growth environments. Be ready to discuss how you’ve navigated challenges and fostered collaboration between product, engineering, and clinical teams. This will highlight your ability to lead a small, high-impact team effectively.
✨Demonstrate Strategic Thinking
Think about how you would approach building a global regulatory roadmap. Be prepared to discuss your strategic vision and how you would balance hands-on execution with long-term planning. This will illustrate your capability to operate in ambiguous and fast-evolving regulatory landscapes.
✨Engage with Real-World Scenarios
Be ready to discuss real-world examples where you've successfully partnered with regulators or navigated audits. Sharing specific experiences will help you connect with the interviewers and demonstrate your practical understanding of compliance and regulatory affairs.