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- Tasks: Support global product registrations and collaborate with teams on regulatory compliance.
- Company: Join a leading medical device manufacturer with a strong regulatory team.
- Benefits: Gain hands-on experience, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in the medical field while working with innovative Class III devices.
- Qualifications: Experience in Regulatory Affairs and knowledge of Class III medical devices required.
- Other info: Dynamic work environment with a focus on collaboration and international market access.
The predicted salary is between 36000 - 60000 £ per year.
Cure Talent are delighted to be partnered with a medical device manufacturer as they look to strengthen their Regulatory Affairs capability. We have an exciting opportunity for a Regulatory Affairs Specialist to join an established regulatory team and support international market access activities for complex medical devices.
As the new Regulatory Affairs Specialist, you will support worldwide product registrations and lifecycle maintenance, working closely with the Regulatory Affairs Manager to ensure products meet international regulatory requirements. This is a hands-on role with strong exposure to technical documentation, Class III devices, and cross-functional collaboration with Sales, Marketing, and technical teams.
Key Responsibilities- Support worldwide product registration submissions and ongoing maintenance activities.
- Assist with new product registrations across international markets.
- Maintain Design Dossiers and Technical Files in line with regulatory requirements.
- Support complaint file reviews and regulatory programmes for new and existing products.
- Work closely with Sales and Marketing to ensure labelling, advertising, and promotional materials comply with applicable regulations.
- Support the regulatory function to ensure timely and compliant delivery of products to market.
- Prepare Rest of World submissions following internal review and approval.
- Experience working in a Regulatory Affairs support role within a medical device company.
- Knowledge and experience working with Class III medical devices.
- Strong understanding of regulatory frameworks applicable to Class III devices.
- Experience writing and maintaining technical documentation.
- Calm, confident communicator able to work effectively with technical stakeholders.
- Knowledge or experience working to ISO 13485 is desirable.
If you’re a Regulatory Affairs professional looking to build further experience across international registrations and Class III devices within a collaborative medical device environment, we’d love to hear from you.
Regulatory Affairs Specialist employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist
✨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 dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of Class III devices and international regulations. We recommend practising common interview questions with a friend to boost your confidence and ensure you shine during the real deal.
✨Tip Number 3
Showcase your technical documentation skills! Bring examples of your work to interviews, as this will demonstrate your hands-on experience and understanding of the regulatory landscape. We love seeing candidates who can back up their claims with solid evidence.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always on the lookout for passionate individuals ready to make an impact in the regulatory affairs space.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Regulatory Affairs, especially with Class III medical devices. We want to see how your skills align with the job description, so don’t be shy about showcasing relevant projects or roles you've had.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your background makes you a perfect fit for our team. Keep it concise but impactful – we love a good story!
Showcase Your Technical Skills: Since this role involves a lot of technical documentation, make sure to mention any specific tools or methodologies you’ve used. If you’ve worked with ISO 13485 or similar frameworks, let us know – it’ll definitely catch our eye!
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 the role. Plus, it’s super easy – just follow the prompts and you’re good to go!
How to prepare for a job interview at Cure Talent
✨Know Your Regulations
Make sure you brush up on the regulatory frameworks relevant to Class III medical devices. Familiarise yourself with ISO 13485 and any specific regulations that might apply to the company’s products. This knowledge will not only help you answer questions confidently but also show your genuine interest in the role.
✨Showcase Your Documentation Skills
Prepare examples of technical documentation you've worked on in the past. Be ready to discuss how you maintained design dossiers and technical files, as this is crucial for the role. Highlighting your experience in writing and reviewing these documents will demonstrate your hands-on capability.
✨Collaborate Like a Pro
Since this role involves working closely with Sales, Marketing, and technical teams, think of instances where you successfully collaborated across departments. Share specific examples that showcase your communication skills and ability to work effectively with diverse stakeholders.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills in regulatory affairs. Think about challenges you've faced in previous roles and how you overcame them. This will help you articulate your thought process and decision-making abilities during the interview.
