At a Glance
- Tasks: Lead regulatory activities for innovative medical devices and collaborate with global teams.
- Company: Join a globally recognised medical device organisation with a strong international presence.
- Benefits: Competitive salary, career growth opportunities, and a chance to work on high-profile projects.
- Other info: Dynamic role focused on technical ownership and cross-functional collaboration.
- Why this job: Make a real impact by bringing cutting-edge medical devices to market across Europe.
- Qualifications: Proven experience in Regulatory Affairs within the Medical Device sector and knowledge of MDR 2017/745.
The predicted salary is between 60000 - 80000 £ per year.
Cure Talent are delighted to be partnered with a global medical device organisation recognised as one of the most established and successful healthcare companies in the world. With a strong international presence and continued investment into next-generation technologies, the business is continuing to expand its regulatory capability across high-profile product programmes.
We have an opportunity for a Principal Regulatory Affairs Specialist to join the organisation and support the development and approval of a brand new medical device programme under MDR 2017/745. Working as part of a highly experienced global Regulatory Affairs function, this role will play a key part in helping bring an innovative new product to market across Europe.
The position is centred around technical Regulatory Affairs ownership and cross-functional project leadership rather than people management. You will work closely with R&D, Clinical and global Regulatory teams throughout the product development lifecycle, supporting regulatory activities from early-stage development through to submission and approval. Alongside this, you will contribute to the regulatory strategy for the programme, helping define approval pathways, manage regulatory risk and support interactions with Notified Bodies and Competent Authorities.
To be successful as the new Principal Regulatory Affairs Specialist, you will have proven Regulatory Affairs experience within the Medical Device sector alongside strong working knowledge of MDR 2017/745. You will have experience supporting new product development activities, contributing to regulatory submissions and operating within cross-functional product development environments. Experience with Class III devices or combination products would be advantageous, but is not essential.
Key Responsibilities- Support the development and approval activities for a new medical device programme under MDR 2017/745.
- Work closely with global Regulatory Affairs, Clinical Affairs and R&D teams across the product development lifecycle.
- Contribute to regulatory strategy activities and support the definition of EU approval pathways.
- Develop and maintain regulatory plans aligned to product development and submission milestones.
- Provide regulatory input into technical documentation, risk management and clinical activities.
- Proven Regulatory Affairs experience within the Medical Device sector.
- Strong working knowledge of MDR 2017/745 and associated regulatory frameworks.
- Experience supporting regulatory activities for medical device development programmes.
- Experience contributing to regulatory submissions and technical documentation activities.
- Experience with Class III medical devices, combination products or drug-device products would be advantageous but is not essential.
- Degree qualified within a scientific, engineering or related discipline.
This is an opportunity to join a globally recognised medical device organisation working on a high-profile development programme where Regulatory Affairs sits at the centre of product development and market approval activities. If you enjoy technically focused Regulatory Affairs work, collaborative project environments and supporting innovative products through to market launch, please get in touch with Kris Holmes today or click apply now.
Principal Regulatory Affairs Specialist in Oxford employer: Cure Talent
Join a dynamic and innovative medical device manufacturer in Slough, where your role as Procurement Manager will not only enhance your career but also contribute to meaningful healthcare solutions. With a strong focus on employee development, a collaborative work culture, and the opportunity to manage significant procurement budgets, this position offers a unique chance to make a real impact while enjoying a supportive environment that values growth and excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Principal Regulatory Affairs Specialist in Oxford
✨Tip Number 1
Network like a pro! Reach out to professionals in the Regulatory Affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Principal Regulatory Affairs Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of MDR 2017/745 and recent developments in medical device regulations. We want you to shine when discussing your experience and how it aligns with the company's goals.
✨Tip Number 3
Showcase your cross-functional collaboration skills! Be ready to share examples of how you've worked with R&D, Clinical, and Regulatory teams in the past. We know that teamwork is key in this role, so let that shine through.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re here to help you every step of the way, so take that leap and submit your application today!
We think you need these skills to ace Principal Regulatory Affairs Specialist in Oxford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Principal Regulatory Affairs Specialist role. Highlight your experience with MDR 2017/745 and any relevant projects you've worked on. 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 regulatory affairs in the medical device sector. Share specific examples of your achievements and how they relate to the role. We love a good story!
Showcase Your Teamwork Skills:Since this role involves working closely with R&D and Clinical teams, make sure to highlight your collaborative experiences. We value teamwork, so let us know how you've successfully worked in cross-functional environments before.
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to submit all your documents in one go. Plus, we love seeing applications come directly from our site!
How to prepare for a job interview at Cure Talent
✨Know Your MDR Inside Out
Make sure you have a solid understanding of MDR 2017/745 and how it applies to the medical device sector. Brush up on key regulations and be ready to discuss how you've navigated these in your previous roles.
✨Showcase Cross-Functional Collaboration
Prepare examples that highlight your experience working with R&D, Clinical Affairs, and other teams. Be ready to explain how you’ve contributed to regulatory strategies and supported product development across different functions.
✨Demonstrate Technical Expertise
Be prepared to discuss your experience with technical documentation and regulatory submissions. Highlight any specific projects where you played a key role in developing regulatory plans or managing risk.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions about the company’s regulatory strategy or upcoming projects. This shows your genuine interest in the role and helps you gauge if the company is the right fit for you.
