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- Tasks: Support global product registrations and ensure compliance with international regulations.
- Company: Join a leading Medical Device Manufacturer experiencing exceptional growth.
- Benefits: Enjoy a hybrid work model with flexible on-site requirements.
- Why this job: Be part of a team that ensures global compliance and impacts healthcare positively.
- Qualifications: Experience in Regulatory Affairs, especially with Class III Medical Devices, is essential.
- Other info: Opportunity to work in a dynamic environment with a focus on innovation.
The predicted salary is between 36000 - 60000 £ per year.
Cure Talent is thrilled to partner with a leading Medical Device Manufacturer who, due to their exceptional continued growth, have an exciting opportunity for a Regulatory Affairs Associate to join their team. As the new Regulatory Affairs Associate, you will be responsible for supporting global product registrations for both new and existing devices, maintaining technical files & design dossiers and ensuring compliance with international regulatory requirements.
To be successful as the new Regulatory Affairs Associate, we are looking for an experienced Regulatory Affairs professional who ideally has experience with Class III devices and has experience of coordinating new and/or existing product registrations. This is a hybrid role with the expectation of being on site in Didcot twice a week.
Key Responsibilities:- Coordinate worldwide product registrations and compliance
- Maintain and update technical files and design dossiers
- Support post-market surveillance obligations and associated reporting
- Review technical, marketing, and legal documentation for regulatory compliance
- Support regulatory activities related to change note approvals and complaint file reviews
- Assist in delivering new and existing products in compliance with global regulatory standards
- Proven experience in a Regulatory Affairs role in Medical Devices
- Knowledge and experience of Class III Medical Devices
- Proven experience with technical file creation, maintenance and development
- Strong working knowledge and experience with ISO 13485
- Knowledge of Product Registrations, preferably Worldwide
If you are passionate about regulatory affairs and want to play a pivotal role in ensuring global compliance within a respected Medical Device Manufacturer, we would love to hear from you.
Regulatory Affairs Associate employer: Cure Talent Ltd
Contact Detail:
Cure Talent Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Associate
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements for Class III medical devices. Understanding the nuances of these regulations will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who work with medical devices. Attend industry events or join relevant online forums to gain insights and potentially get referrals.
✨Tip Number 3
Prepare to discuss your experience with technical file creation and maintenance in detail. Be ready to share specific examples of how you've ensured compliance in past roles, as this will be crucial for the position.
✨Tip Number 4
Research the company’s recent product launches and regulatory achievements. This knowledge will allow you to tailor your conversation during interviews and show that you're genuinely interested in their work.
We think you need these skills to ace Regulatory Affairs Associate
Some tips for your application 🫡
Understand the Role: Read the job description carefully to understand the key responsibilities and requirements for the Regulatory Affairs Associate position. Tailor your application to highlight your relevant experience with Class III devices and regulatory compliance.
Highlight Relevant Experience: In your CV and cover letter, emphasise your proven experience in Regulatory Affairs, particularly with medical devices. Include specific examples of your work with technical files, product registrations, and compliance with ISO 13485.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for regulatory affairs and your understanding of the industry. Mention how your skills align with the company's needs and express your enthusiasm for contributing to their success.
Proofread Your Application: Before submitting your application, thoroughly proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in the regulatory field.
How to prepare for a job interview at Cure Talent Ltd
✨Showcase Your Regulatory Knowledge
Make sure to brush up on your knowledge of regulatory affairs, especially regarding Class III medical devices. Be prepared to discuss specific regulations and standards, such as ISO 13485, and how they apply to product registrations.
✨Demonstrate Your Experience
Highlight your previous experience in coordinating product registrations and maintaining technical files. Use specific examples from your past roles to illustrate your expertise and how it aligns with the responsibilities of the Regulatory Affairs Associate position.
✨Prepare for Compliance Questions
Expect questions related to compliance and post-market surveillance. Familiarise yourself with common challenges faced in regulatory affairs and be ready to discuss how you have successfully navigated these issues in your previous roles.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory processes and their approach to global compliance. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
