At a Glance
- Tasks: Lead regulatory submissions for medical devices across the UK, EU, and US.
- Company: Growing medical device business with a focus on innovation.
- 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 and strong knowledge of FDA and EU MDR.
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.
Regulatory Submissions Lead - Medical Devices in Basingstoke 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 encourages innovation and collaboration, allowing you to take ownership of your projects while working remotely from anywhere in the UK. Join a small but ambitious team that values your expertise and offers the chance to make a significant impact in the medical device industry as it expands into new markets.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Submissions Lead - Medical Devices in Basingstoke
✨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 EU MDR and FDA requirements. Be ready to discuss your experience with 510(k) and De Novo submissions, as well as how you've influenced stakeholders in past roles. Confidence is key!
✨Tip Number 3
Showcase your hands-on experience! When chatting with potential employers, highlight specific projects where you led regulatory submissions or developed strategies. This will demonstrate your ability to take ownership and thrive in a fast-paced environment.
✨Tip Number 4
Don't forget to apply through our website! We’ve got loads of resources to help you land that dream job, and applying directly can give you an edge. Plus, it shows you're serious about joining our team!
We think you need these skills to ace Regulatory Submissions Lead - Medical Devices in Basingstoke
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 the medical device sector. Mention how your background aligns with our needs and how you can contribute to our growth story.
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 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. Familiarise yourself with the 510(k), De Novo, and Q-Sub processes, as these will be crucial in your role. Being able to discuss these confidently will show that you're not just knowledgeable but also passionate about regulatory affairs.
✨Showcase Your Hands-On Experience
Since this is a hands-on role, be ready to share specific examples from your past experiences where you've led regulatory submissions or developed strategies. Highlight any challenges you faced and how you overcame them, as this will demonstrate your problem-solving skills and ability to thrive in a fast-paced environment.
✨Prepare for Cross-Functional Collaboration
This role requires working closely with various teams like Quality, Clinical, and R&D. Think of examples where you've successfully influenced stakeholders or collaborated across departments. This will illustrate your ability to work well in a team and balance detail with a commercial mindset.
✨Ask Insightful Questions
Interviews are a two-way street, so prepare some thoughtful questions about the company's growth plans and regulatory strategy. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals. Plus, it gives you a chance to engage with the interviewers on a deeper level.
