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- Tasks: Support global product registrations and ensure compliance with regulatory standards.
- Company: Join a leading Medical Device Manufacturer known for exceptional growth and innovation.
- Benefits: Enjoy a hybrid work model with flexibility and opportunities for professional development.
- Why this job: Be part of a dynamic team making a real impact in healthcare through regulatory excellence.
- Qualifications: Experience in Regulatory Affairs, especially with Class III devices, is essential.
- Other info: Work on-site in Didcot twice a week while contributing to global compliance efforts.
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 and 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
Contact Detail:
Cure Talent 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 boost your confidence during 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. Engaging in conversations can provide you with insights into the industry and may even lead to referrals or recommendations.
✨Tip Number 3
Stay updated on the latest trends and changes in global regulatory standards. This knowledge will not only prepare you for potential interview questions but also show that you are proactive and dedicated to your professional development.
✨Tip Number 4
Prepare to discuss specific examples from your past experience where you successfully coordinated product registrations or maintained technical files. Being able to articulate your achievements will set you apart from other candidates.
We think you need these skills to ace Regulatory Affairs Associate
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the key responsibilities and requirements for the Regulatory Affairs Associate position. Tailor your application to highlight 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, carefully proofread all documents for spelling and grammatical errors. 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
✨Know Your Regulations
Familiarise yourself with the specific regulations surrounding Class III medical devices. Be prepared to discuss how these regulations impact product registrations and compliance, as this will demonstrate your expertise in the field.
✨Showcase Your Experience
Prepare examples from your previous roles that highlight your experience with technical file creation and maintenance. Discuss any challenges you faced and how you overcame them, as this will show your problem-solving skills.
✨Understand the Company’s Products
Research the company’s product line and their regulatory history. Being able to speak knowledgeably about their devices and how they fit into the global market will impress the interviewers and show your genuine interest in the role.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory processes and future projects. This not only shows your enthusiasm for the position but also your proactive approach to understanding the role's responsibilities.
