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- Tasks: Lead regulatory activities for a novel combination product and ensure compliance with global standards.
- Company: Join a leading medical device manufacturer at the forefront of innovative technology.
- Benefits: Attractive salary, bonuses, private healthcare, and wellness initiatives.
- Other info: Dynamic on-site environment with opportunities for professional growth and collaboration.
- Why this job: Make a real impact in the medical field while working on cutting-edge products.
- Qualifications: 5+ years in Regulatory Affairs with experience in medical devices and combination products.
The predicted salary is between 75000 - 90000 £ per year.
Location: West Oxford, UK – 100% on site (Relocation support can be offered)
Job Type: Full-time, Permanent
Salary: £75,000 - £90,000 + Bonus + LTI’s
Cpl Life Sciences is collaborating with one of the world's leading medical device manufacturers, who are looking for an experienced Regulatory Affairs Manager to support the development and approval of a novel combination product/device. This is a hands-on, specialist role focused exclusively on a single, innovative product programme, offering the opportunity to work at the forefront of cutting-edge technology. This is a non-linear management position, ideal for a technically strong regulatory professional who thrives on ownership, detail, and end-to-end product involvement.
Key Responsibilities:
- The role requires strong expertise in CE Marking, MDR, experience engaging with Competent Authorities and Notified Bodies, and a solid background in CTD dossier authoring.
- Lead regulatory activities for a novel combination product/device, supporting development through to approval and lifecycle.
- Own and execute regulatory strategy for a single, high-priority product programme.
- Act as the regulatory SME for combination product classification and pathway definition.
- Support and contribute to the authoring and maintenance of CTD dossiers (Modules 1–5).
- Ensure alignment between device technical documentation and medicinal product submissions.
- Work directly with Competent Authorities, Notified Bodies, MHRA, EMA, and other global regulators.
- Prepare briefing documents, support meetings, and manage responses to regulatory queries.
- Partner closely with R&D, Quality, Clinical, and Manufacturing teams.
- Support integration of device and pharmaceutical regulatory requirements within the product development lifecycle.
Experience Required:
- Degree in Life Sciences, Pharmacy, Engineering, or related discipline - Advanced degree preferred.
- 5+ years in Regulatory Affairs, ideally within medical devices and combination products.
- Hands-on experience leading a combination product to market in the UK and Europe.
- Experience working with Competent Authorities and/or Notified Bodies.
- Familiarity with design control and risk management standards.
- Strong communication and cross-functional collaboration skills.
- Ability to operate in a focused, delivery-driven environment with high ownership.
- Effective communicator with confidence working with regulatory authorities.
Why join the business:
- Attractive salary, including a 15% bonus, LTIs (Up to $12,000), private healthcare, pension, life assurance, dental care + other benefits.
- Full manufacturing + R&D labs + Clean rooms + Corporate office on site.
- Regular events on site, including Pilates and yoga.
- On-site canteen and restaurant.
- Wellness room.
For more information, please contact lucy.kirkaldy@cpl.com
Regulatory Affairs Manager - Combination Product employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager - Combination Product
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those who work at companies you're interested in. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Show them you’re not just another candidate; you’re genuinely excited about their innovative combination product and how you can contribute to its success.
✨Tip Number 3
Practice your pitch! Be ready to explain your experience in Regulatory Affairs clearly and confidently. Highlight your hands-on experience with CE Marking and working with Competent Authorities to show you’re the right fit.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and take the initiative to connect with us directly.
We think you need these skills to ace Regulatory Affairs Manager - Combination Product
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience with CE Marking, MDR, and CTD dossier authoring. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this specific combination product and how your skills can contribute to its success. Let us know what makes you the perfect fit!
Showcase Your Communication Skills: Since this role involves working closely with various teams and regulatory authorities, make sure to highlight your communication skills in your application. We love candidates who can articulate their thoughts clearly and confidently!
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’re considered for this exciting opportunity. Don’t miss out!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of CE Marking, MDR, and CTD dossier authoring. Be ready to discuss specific examples from your experience where you've successfully navigated these areas, as this will show your expertise and confidence in regulatory affairs.
✨Showcase Your Collaboration Skills
This role requires working closely with various teams like R&D, Quality, and Clinical. Prepare to share examples of how you've effectively collaborated in the past, highlighting your communication skills and ability to work cross-functionally.
✨Understand the Product Lifecycle
Familiarise yourself with the entire lifecycle of a combination product. Be prepared to discuss how you would approach regulatory strategy from development through to approval, demonstrating your ownership and detail-oriented mindset.
✨Prepare for Regulatory Authority Interactions
Since you'll be engaging with Competent Authorities and Notified Bodies, think about how you would handle regulatory queries or prepare briefing documents. Practising responses to potential questions can help you feel more confident during the interview.