At a Glance
- Tasks: Lead regulatory submissions for medical devices across the UK, EU, and US.
- Company: Growing medical device business with a dynamic and innovative culture.
- Benefits: Competitive salary up to £80,000 and fully remote work.
- Other info: Must be based in the UK with the right to work.
- Why this job: Take ownership in a fast-paced environment and shape regulatory strategies.
- Qualifications: 10+ years in medical device regulatory affairs with strong EU and FDA knowledge.
The predicted salary is between 80000 - 80000 € per year.
Cpl Life Sciences is partnering with a small but growing medical device business that has recently secured funding and is now looking to hire a Regulatory Submissions Lead to support its next phase of growth. This is a hands-on role with real ownership — ideal for someone who enjoys working across strategy and execution in a fast-moving environment.
You’ll be responsible for leading regulatory submissions across the UK, EU, and US, including FDA 510(k), De Novo, and Q-Subs, while acting as a key point of contact for regulators and notified bodies. Alongside submissions, you’ll play a big part in shaping regulatory strategy, ensuring compliance across the full product lifecycle, and supporting the business as it expands into new markets.
Key Responsibilities- Lead global regulatory submissions (FDA, EU MDR, UKCA)
- Prepare and manage 510(k), De Novo and FDA pre-submissions
- Represent the business in FDA and regulatory authority interactions
- Develop regulatory strategies, including classification and market pathways
- Carry out gap analysis on technical documentation and clinical evidence
- Maintain clinical evaluation reports (CERs) and technical files
- Review product claims, labelling and promotional material
- Support post-market surveillance and regulatory compliance activities
- Work closely with Quality, Clinical, R&D and commercial teams
- Around 10+ years of experience in medical device regulatory affairs
- Strong knowledge of EU MDR and FDA requirements
- Experience with 510(k), De Novo, and Q-Sub processes
- Comfortable working cross-functionally and influencing stakeholders
- Able to balance detail with a practical, commercial mindset
- Must be based in the UK and have the right to work in the UK
- Fully remote role
For more information, please reach out - This role does not offer sponsorship; you must hold the full right to work.
Locations
Regulatory Submissions Lead - Medical Devices in Hampshire, Portsmouth employer: Cpl Life Sciences
Join a dynamic and innovative medical device company that values your expertise and offers a fully remote working environment, allowing for a perfect work-life balance. With a strong focus on employee growth and development, you'll have the opportunity to lead impactful regulatory submissions while shaping the future of the business as it expands into new markets. Enjoy a collaborative culture where your contributions are recognised and rewarded, making this an excellent place for professionals seeking meaningful and rewarding employment.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Submissions Lead - Medical Devices in Hampshire, Portsmouth
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the hunt for a Regulatory Submissions Lead role. You never know who might have the inside scoop on openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA 510(k) and EU MDR processes. Be ready to discuss your past experiences and how they relate to the responsibilities of the role. We want to see that you can hit the ground running!
✨Tip Number 3
Showcase your strategic thinking! When discussing your approach to regulatory submissions, highlight how you've developed strategies in the past and how you plan to tackle challenges in this new role. We love candidates who can think ahead!
✨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 serious about joining our team and contributing to our growth in the medical device sector.
We think you need these skills to ace Regulatory Submissions Lead - Medical Devices in Hampshire, Portsmouth
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Submissions Lead role. Highlight your experience with FDA submissions and EU MDR compliance, as these are key for us. Use specific examples that showcase your hands-on approach and strategic thinking.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Tell us why you're passionate about regulatory affairs in medical devices. Mention how your background aligns with our needs and how you can contribute to our growth. Keep it engaging and personal!
Showcase Your Cross-Functional Skills:We love candidates who can work across teams! In your application, highlight any experiences where you've collaborated with Quality, Clinical, or R&D teams. This will show us that you can influence stakeholders effectively.
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. Plus, it gives you a chance to explore more about our company culture and values.
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulations Inside Out
Make sure you brush up on the latest EU MDR and FDA requirements. Being able to discuss specific regulations and how they apply to the role will show that you're not just familiar with the basics, but that you’re ready to hit the ground running.
✨Prepare for Scenario Questions
Expect questions about how you would handle specific regulatory challenges, like preparing a 510(k) submission or interacting with regulators. Think of examples from your past experience where you successfully navigated similar situations and be ready to share those stories.
✨Show Your Strategic Thinking
This role involves shaping regulatory strategy, so be prepared to discuss your approach to developing market pathways and conducting gap analyses. Highlight any previous experiences where you’ve had to think strategically and how it benefited your team or project.
✨Engage with Cross-Functional Teams
Since this position requires collaboration with various teams, be ready to talk about how you've worked cross-functionally in the past. Share examples of how you influenced stakeholders and ensured compliance while balancing detail with a commercial mindset.
