At a Glance
- Tasks: Shape regulatory strategy and product direction for innovative medical technologies.
- Company: Join a pioneering regulatory intelligence platform transforming the SaMD landscape.
- Benefits: Equity-based compensation with a standard vesting schedule.
- Other info: Collaborate directly with the founder and influence strategic decisions from day one.
- Why this job: Make a real impact in regulatory clarity for cutting-edge AI/ML medical devices.
- Qualifications: Senior regulatory leadership experience in S/AIaMD across multiple jurisdictions.
The predicted salary is between 60000 - 80000 € per year.
Regulatory compliance for S/AIaMD is complex. The rules are dense, the frameworks differ by jurisdiction, and the cost of getting it wrong (delayed launches, failed audits, wasted development cycles) falls hardest on the teams least equipped to absorb it. Regi was built to change that. We're a regulatory intelligence platform purpose-built for SaMD and AI-enabled medical technologies. We help product teams, founders, and compliance leads understand exactly what's required to bring a device to market (across FDA, EU MDR, and UKCA frameworks) without needing a full regulatory affairs function in-house. We work with teams from early-stage product development through to multi-device post-market compliance across multiple jurisdictions. We're built around the core belief that regulatory clarity shouldn't be a competitive advantage available only to large, well-resourced organisations.
The role involves working directly with the founder on regulatory strategy, product direction, and commercial development. This is a working advisory position. The right person will have substantive operational and strategic input from day one. The remit includes, but is not limited to:
- Pressure-testing Regi's positioning on new and emerging guidance across supported jurisdictions
- Shaping decisions on where the platform deepens regulatory coverage next, including jurisdictional expansion priorities
- Making warm introductions across your network to support Regi's commercial pipeline
- Bringing senior commercial judgement to pricing and positioning
- Connecting Regi to current regulator and notified body thinking on AI/ML topics
- Acting as a senior sounding board on regulatory science and ecosystem strategy
What makes you a great fit:
- Senior regulatory leadership in S/AIaMD with substantive experience across at least two of our supported jurisdictions (UKCA, EU MDR, FDA)
- A track record of owning or leading high risk device submissions
- An active network across UK/EU/US regulatory science
- Fluency in AI/ML-specific regulatory considerations: change control, PCCPs, transparency, bias evaluation, post-market performance monitoring
- Prior advisory or non-executive experience with venture-backed companies
Compensation and structure: Equity-based advisory engagement on a standard vesting schedule.
Regulatory Advisor (S/AIaMD) in London employer: Regi
Regi is an exceptional employer that champions regulatory clarity in the complex landscape of S/AIaMD, offering a unique opportunity for Regulatory Advisors to work closely with the founder on impactful strategies. Our collaborative work culture fosters innovation and growth, providing employees with the chance to shape the future of medical technology while benefiting from equity-based compensation and a supportive network. Located at the heart of a thriving tech ecosystem, Regi empowers its team members to make meaningful contributions that drive both personal and professional development.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Advisor (S/AIaMD) in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory space and let them know you're on the lookout for opportunities. A warm introduction can make all the difference, so don’t be shy about asking for help.
✨Tip Number 2
Stay updated on the latest regulatory trends and guidance. Join relevant forums or groups where you can engage with others in the field. This not only boosts your knowledge but also shows potential employers that you're proactive and passionate about the industry.
✨Tip Number 3
When you get an interview, come prepared with insights on Regi's positioning and how you can contribute to their mission. Show them you understand the complexities of S/AIaMD and have ideas on navigating those challenges.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows your enthusiasm for joining the Regi team and being part of something innovative in the regulatory landscape.
We think you need these skills to ace Regulatory Advisor (S/AIaMD) in London
Some tips for your application 🫡
Know Your Stuff:Make sure you really understand the regulatory landscape for S/AIaMD. Highlight your experience with UKCA, EU MDR, and FDA in your application. We want to see that you can navigate these frameworks like a pro!
Show Your Impact:When detailing your past roles, focus on the impact you've made. Did you lead high-risk device submissions? Share those stories! We love to see how you've shaped regulatory strategies and influenced product direction.
Network Like a Boss:If you’ve got connections in the regulatory world, flaunt them! Mention any warm introductions you can make or how your network can support our commercial pipeline. It’s all about collaboration at Regi!
Tailor Your Application:Don’t just send a generic CV and cover letter. Tailor your application to reflect how your skills align with our mission at Regi. Show us why you’re the perfect fit for this advisory role. And remember, apply through our website!
How to prepare for a job interview at Regi
✨Know Your Regulations
Make sure you brush up on the specific regulations related to S/AIaMD, especially the FDA, EU MDR, and UKCA frameworks. Being able to discuss these in detail will show that you understand the complexities of regulatory compliance and can contribute meaningfully from day one.
✨Showcase Your Network
Be prepared to talk about your connections within the regulatory landscape. Mention any warm introductions you've made in the past or how your network could benefit Regi's commercial pipeline. This demonstrates your proactive approach and ability to leverage relationships for the company's advantage.
✨Demonstrate Strategic Thinking
Think about how you would pressure-test Regi's positioning on new guidance. Prepare examples of how you've shaped decisions in previous roles regarding regulatory coverage or jurisdictional expansion. This will highlight your strategic mindset and operational experience.
✨Discuss AI/ML Considerations
Since the role involves AI/ML topics, be ready to discuss your fluency in regulatory considerations specific to these technologies. Bring up any relevant experiences with change control, bias evaluation, or post-market performance monitoring to showcase your expertise in this area.
