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For Companies At a Glance
- Tasks: Lead global regulatory strategy for innovative AI medical devices and ensure compliance.
- Company: Fast-growing healthcare digital health company 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 leadership experience.
- Other info: Join a high-impact team in a fast-paced, evolving environment.
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 will own the global regulatory roadmap across UK, EU, US and emerging markets, combining strategic leadership with hands-on execution. You will 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 Portsmouth 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 Portsmouth
✨Tip Number 1
Network like a pro! Reach out to folks in the regulatory affairs space, especially those who have experience with SaMD. 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 chat with potential employers, highlight your hands-on experience in navigating regulatory frameworks. They want to see how you can lead their compliance strategy.
✨Tip Number 3
Be ready for a deep dive! If you land an interview, expect questions about your experience in fast-evolving environments. Prepare examples that demonstrate your strategic thinking and adaptability.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Head of Regulatory Affairs in Portsmouth
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 any relevant achievements.
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 your experience with navigating regulatory frameworks and how you can contribute to our high-growth environment.
Showcase Your Cross-Functional Experience: We want to see how you’ve worked with product and engineering teams in the past. Share specific examples that demonstrate your ability to lead and collaborate across different functions.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at GxPeople Global
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations surrounding Software as a Medical Device (SaMD) and AI. 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 high-pressure environments. Think about times when you navigated complex regulatory challenges or collaborated with cross-functional teams. Highlighting your leadership style and how it aligns with the company's goals can really set you apart.
✨Be Ready for Scenario Questions
Expect to face questions that put you in hypothetical situations related to regulatory challenges. Practice articulating your thought process and decision-making strategies. This will demonstrate your ability to think critically and adapt in fast-evolving environments.
✨Engage with the Interviewers
Don’t just wait for questions; engage with your interviewers by asking insightful questions about their current regulatory challenges and future plans. This shows your genuine interest in the role and helps you gauge if the company is the right fit for you.
