At a Glance
- Tasks: Lead regulatory submissions for medical devices across the UK, EU, and US.
- Company: Join a growing medical device business with exciting funding and growth opportunities.
- Benefits: Competitive salary up to £80,000 and fully remote work.
- Other info: Work cross-functionally and influence key stakeholders in a dynamic setting.
- Why this job: Take ownership in a fast-paced environment and shape regulatory strategies.
- Qualifications: 10+ years in medical device regulatory affairs with strong knowledge of EU MDR and FDA.
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 - lucy.kirkaldy@cpl.com. This role does not offer sponsorship; you must hold the full right to work.
Regulatory Submissions Lead - Medical Devices employer: Cpl Life Sciences
Cpl Life Sciences is an excellent employer for those seeking a dynamic and impactful role in the medical device sector. With a fully remote working environment, employees enjoy flexibility while contributing to meaningful projects that shape regulatory strategies and compliance across global markets. The company fosters a collaborative culture that encourages professional growth and offers the opportunity to take ownership of significant regulatory submissions, making it an ideal place for experienced professionals looking to advance their careers.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Submissions Lead - Medical Devices
✨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 job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA, EU MDR, and UKCA regulations. We want you to be able to discuss your experience with 510(k) and De Novo submissions confidently. Show them you’re not just a candidate, but the candidate!
✨Tip Number 3
Don’t forget to showcase your cross-functional collaboration skills! Be ready to share examples of how you've worked with Quality, Clinical, R&D, and commercial teams in the past. This will highlight your ability to influence stakeholders effectively.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us. Let’s get you that dream job!
We think you need these skills to ace Regulatory Submissions Lead - Medical Devices
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 510(k), De Novo, and EU MDR processes. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this hands-on role. Share specific examples of your past successes in regulatory submissions and strategy development.
Showcase Your Cross-Functional Skills:Since this role involves working closely with various teams, make sure to highlight your ability to collaborate and influence stakeholders. We love candidates who can balance detail with a practical mindset!
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 don’t miss out on any important updates from us during the process!
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 Cross-Functional Skills
This role requires collaboration with various teams like Quality, Clinical, and R&D. Prepare examples of how you've successfully worked across departments in the past. Highlighting your ability to influence stakeholders will demonstrate that you can thrive in a fast-moving environment.
✨Prepare for Real-World Scenarios
Think about potential challenges you might face in this role and how you would tackle them. For instance, consider how you would handle a gap analysis on technical documentation or manage a regulatory submission timeline. This will help you stand out as someone who is proactive and solution-oriented.
✨Ask Insightful Questions
Interviews are a two-way street, so come prepared with questions that show your interest in the company’s growth and regulatory strategy. Ask about their approach to market expansion or how they ensure compliance throughout the product lifecycle. This will not only give you valuable insights but also demonstrate your enthusiasm for the role.
