At a Glance
- Tasks: Support global product registrations and maintain compliance for medical devices.
- Company: Join a leading medical device manufacturer with a collaborative regulatory team.
- Benefits: Gain hands-on experience, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare by ensuring products meet international standards.
- Qualifications: Experience in Regulatory Affairs and knowledge of Class III medical devices required.
- Other info: Dynamic role with exposure to cross-functional teams and international markets.
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 in Oxford employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land 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. Building connections can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of Class III devices and regulatory frameworks. We recommend practising common interview questions and having examples ready that showcase your experience with technical documentation.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a thank-you email to express your appreciation and reiterate your interest in the role. It keeps you fresh in their minds and shows your enthusiasm.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team and contributing to our mission.
We think you need these skills to ace Regulatory Affairs Specialist in Oxford
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 you can contribute to our team. Be specific about your experience with international market access and technical documentation.
Showcase Your Communication Skills: As a Regulatory Affairs Specialist, you'll need to communicate effectively with various teams. In your application, highlight instances where you've successfully collaborated with Sales, Marketing, or technical teams to ensure compliance and product success.
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. It helps us keep track of applications better and ensures you get the attention you deserve. Plus, it’s super easy!
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 will show your potential employer that you're not just knowledgeable but also genuinely interested in the role.
✨Prepare Your Technical Documentation
Since this role involves a lot of technical documentation, be ready to discuss your experience in writing and maintaining such documents. Bring examples if possible, and be prepared to explain how you ensure compliance with regulatory requirements in your past roles.
✨Showcase Your Collaboration Skills
This position requires working closely with various teams like Sales and Marketing. Think of examples where you've successfully collaborated with cross-functional teams. Highlight your communication skills and how you’ve navigated challenges in past projects.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company’s approach to international market access or how they handle regulatory changes. This shows your enthusiasm for the role and helps you gauge if the company is the right fit for you.