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 strategy.
- Qualifications: 10+ years in medical device regulatory affairs with strong FDA and EU MDR 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
- This role does not offer sponsorship; you must hold the full right to work
Regulatory Submissions Lead - Medical Devices in Milton Keynes employer: Cpl Life Sciences
Cpl Life Sciences is an exceptional employer, offering a dynamic and supportive work environment for the Regulatory Submissions Lead role. With a focus on employee growth and development, the company fosters a culture of collaboration and innovation, allowing you to take ownership of your projects while working remotely from anywhere in the UK. Join a small but ambitious medical device business that values your expertise and provides the opportunity to shape regulatory strategies as it expands into new markets.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Submissions Lead - Medical Devices in Milton Keynes
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device industry on LinkedIn. Join relevant groups and participate in discussions to get your name out there and show off your expertise.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA and EU regulations. Be ready to discuss how your experience aligns with the role, especially around submissions and compliance strategies.
✨Tip Number 3
Don’t just wait for job postings! Reach out directly to companies you’re interested in. Express your enthusiasm for their work and ask if they have any upcoming opportunities that fit your skills.
✨Tip Number 4
Use our website to apply! We’ve got loads of resources to help you stand out. Plus, applying through us means you’ll be in the loop for future roles that match your profile.
We think you need these skills to ace Regulatory Submissions Lead - Medical Devices in Milton Keynes
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 experience in regulatory affairs.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Tell us why you're passionate about medical devices and how your background aligns with our needs. Be sure to mention your strategic thinking and execution skills, as we’re looking for someone who can lead and influence.
Showcase Your Cross-Functional Experience:We love candidates who can work across teams! In your application, highlight any experience you have collaborating with Quality, Clinical, R&D, or commercial teams. This will show us that you can balance detail with a practical mindset.
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 shows us you’re keen on joining our team!
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. Familiarise yourself with the 510(k), De Novo, and Q-Sub processes, as these will likely come up in your interview. Being able to discuss specific regulations confidently will show that you're not just knowledgeable but also passionate about the field.
✨Showcase Your Hands-On Experience
Since this role is all about ownership and execution, be ready to share examples from your past where you've led regulatory submissions or developed strategies. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your impact in previous roles.
✨Prepare for Cross-Functional Questions
This position requires collaboration with various teams like Quality, Clinical, and R&D. Think of instances where you've successfully influenced stakeholders or worked cross-functionally. Be prepared to discuss how you navigate different perspectives and drive consensus.
✨Ask Insightful Questions
Interviews are a two-way street! Prepare thoughtful questions about the company's growth plans, regulatory challenges they face, or how they envision the role evolving. This not only shows your interest but also helps you gauge if the company aligns with your career goals.
