At a Glance
- Tasks: Lead regulatory activities for a novel combination product from development to approval.
- Company: Join a leading medical device manufacturer at the forefront of innovation.
- Benefits: Attractive salary, bonuses, private healthcare, and wellness perks.
- Other info: On-site role with relocation support and a vibrant workplace culture.
- Why this job: Make a real impact in a hands-on role with cutting-edge technology.
- Qualifications: 5+ years in Regulatory Affairs with experience in medical devices.
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.
Regulatory Affairs Manager - Combination Product in Oxford employer: Cpl Life Sciences
Join a leading medical device manufacturer in West Oxford as a Regulatory Affairs Manager, where you will be at the forefront of innovative product development. Enjoy a competitive salary package with bonuses, comprehensive healthcare benefits, and a vibrant work culture that promotes employee well-being through regular on-site events and wellness initiatives. With opportunities for professional growth and a hands-on role in a cutting-edge environment, this position offers a unique chance to make a significant impact in the regulatory landscape of combination products.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager - Combination Product in Oxford
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field, especially those who have experience with combination products. Use platforms like LinkedIn to connect and engage with them; you never know who might have a lead on your dream job!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of CE Marking and MDR regulations. Be ready to discuss your hands-on experience with combination products and how you've successfully navigated regulatory pathways in the past.
✨Tip Number 3
Showcase your passion for the role! When you get the chance to speak with potential employers, highlight your enthusiasm for working at the forefront of cutting-edge technology in medical devices. Let them see that you're not just looking for any job, but this specific opportunity.
✨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 about their job search and genuinely interested in joining our team.
We think you need these skills to ace Regulatory Affairs Manager - Combination Product in Oxford
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 any hands-on work you've done with combination products. 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 role and how your skills make you the perfect fit. Don’t forget to mention your experience with regulatory authorities and CTD dossier authoring.
Showcase Your Communication Skills:Since this role involves working closely with various teams and regulatory bodies, it's crucial to demonstrate your strong communication skills. We love seeing examples of how you've effectively collaborated in the past!
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. Plus, it’s super easy!
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. Being able to discuss these topics confidently will show that you're not just familiar with the basics but are ready to dive deep into the specifics of the role.
✨Showcase Your Experience
Prepare to share specific examples from your past roles where you've successfully led a combination product to market. Highlight your interactions with Competent Authorities and Notified Bodies, as this will demonstrate your hands-on experience and ability to navigate regulatory landscapes.
✨Communicate Clearly
Since this role requires strong communication skills, practice articulating your thoughts clearly and concisely. Be ready to explain complex regulatory concepts in simple terms, as you'll need to collaborate with various teams and stakeholders.
✨Demonstrate Ownership and Detail Orientation
This position is all about taking ownership and being detail-oriented. Prepare to discuss how you've managed projects end-to-end in the past, focusing on how you ensured alignment between technical documentation and submissions. This will show that you can handle the responsibilities of the role effectively.
