At a Glance
- Tasks: Shape regulatory strategy and guide product direction in a dynamic environment.
- Company: Join an innovative regulatory intelligence platform transforming medical tech compliance.
- Benefits: Equity-based compensation with a standard vesting schedule.
- Other info: Collaborate directly with the founder and influence strategic decisions.
- Why this job: Make a real impact on the future of AI-enabled medical technologies.
- Qualifications: Senior regulatory experience in S/AIaMD and a strong network in regulatory science.
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 Slough employer: Regi
Regi is an exceptional employer for those passionate about regulatory compliance in the rapidly evolving field of S/AIaMD. With a commitment to fostering a collaborative and innovative work culture, employees are empowered to contribute directly to strategic decisions and product development from day one. The company offers unique growth opportunities through equity-based advisory roles, allowing team members to shape the future of regulatory intelligence while working alongside industry leaders in a supportive environment.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Advisor (S/AIaMD) in Slough
✨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 webinars or forums where you can engage with industry experts. This not only boosts your knowledge but also shows potential employers that you're proactive and passionate about the field.
✨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 regulatory compliance and how your experience aligns with their needs.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in being part of the Regi team.
We think you need these skills to ace Regulatory Advisor (S/AIaMD) in Slough
Some tips for your application 🫡
Show Your Regulatory Expertise:Make sure to highlight your experience in regulatory leadership, especially in S/AIaMD. We want to see how you've navigated the complexities of regulations like UKCA, EU MDR, and FDA. Share specific examples that demonstrate your ability to manage high-risk device submissions.
Network Like a Pro:Your connections matter! If you have an active network in regulatory science across the UK, EU, and US, let us know. We’re keen on candidates who can make warm introductions and support our commercial pipeline, so don’t hold back on showcasing your relationships.
Be Clear and Concise:When writing your application, clarity is key. We appreciate straightforward language that gets to the point. Avoid jargon unless it’s necessary, and make sure your passion for regulatory clarity shines through. We want to see your personality!
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’re considered for the role. Plus, it shows you’re proactive and engaged with our mission at Regi!
How to prepare for a job interview at Regi
✨Know Your Regulations Inside Out
Make sure you’re well-versed in the regulatory frameworks relevant to S/AIaMD, especially the FDA, EU MDR, and UKCA. Brush up on recent changes and emerging guidance, as this will show your commitment and expertise during the interview.
✨Showcase Your Network
Be prepared to discuss your connections within the regulatory science community. Highlight any warm introductions you've made in the past and how they benefited previous roles. This demonstrates your proactive approach and ability to leverage relationships for the company's advantage.
✨Bring Real-World Examples
Prepare specific examples of high-risk device submissions you've led or owned. Discuss the challenges you faced and how you navigated them. This will illustrate your hands-on experience and strategic thinking, which are crucial for the role.
✨Engage in Thoughtful Discussion
During the interview, don’t just answer questions—engage in a dialogue. Share your insights on current trends in AI/ML regulatory considerations and ask thoughtful questions about Regi's strategy. This shows your genuine interest and helps you assess if the company aligns with your vision.
