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.
- Why this job: Make a real impact in regulatory compliance for cutting-edge AI-enabled 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) 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 meaningfully from day one, working closely with the founder on strategic initiatives. The company offers unique growth opportunities through direct involvement in shaping regulatory strategies and access to a vast network, making it an ideal environment for professionals looking to make a significant impact in the medical technology landscape.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Advisor (S/AIaMD)
✨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. Follow relevant blogs, join forums, and participate in webinars. This knowledge will not only boost your confidence but also show potential employers that you’re genuinely 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 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 you’re proactive and genuinely interested in joining the Regi team.
We think you need these skills to ace Regulatory Advisor (S/AIaMD)
Some tips for your application 🫡
Know Your Stuff:Make sure you really understand the regulatory landscape for S/AIaMD. We want to see that you’ve got a solid grasp of the frameworks like FDA, EU MDR, and UKCA. Show us how your experience aligns with what we do!
Tailor Your Application:Don’t just send a generic CV and cover letter. We love it when applicants personalise their applications to reflect our mission at Regi. Highlight your relevant experience and how it connects to our goals in regulatory compliance.
Show Your Network:If you’ve got connections in the regulatory space, flaunt them! Mention any warm introductions you can make or collaborations you’ve had. We’re all about building relationships, so let us know how you can help expand our network.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re genuinely interested in being part of the Regi team!
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.
✨Leverage Your Network
Be prepared to discuss how your existing network can benefit Regi. Think about potential introductions you could make that would support their commercial pipeline and be ready to share specific examples of how you've done this in the past.
✨Showcase Your Strategic Thinking
This role requires a blend of operational and strategic input. Prepare to discuss how you’ve shaped regulatory strategies in previous roles, particularly in high-risk device submissions. Use concrete examples to illustrate your thought process and decision-making skills.
✨Demonstrate AI/ML Fluency
Since the role involves AI/ML-specific regulatory considerations, be ready to talk about your experience with change control, bias evaluation, and post-market performance monitoring. Highlight any projects where you’ve navigated these complexities successfully.
