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- Tasks: Support global product registrations and maintain technical documentation for medical devices.
- Company: Leading medical device manufacturer with a diverse global portfolio.
- Benefits: Full-time role with career development in a supportive team environment.
- Why this job: Make a real impact on patient safety and compliance in the medical field.
- Qualifications: Degree in science/engineering and 3-5 years in Regulatory Affairs.
- Other info: Collaborative culture with opportunities for growth in a multinational setting.
The predicted salary is between 36000 - 60000 £ per year.
A leading medical device manufacturer based in South Wales is seeking a Regulatory Specialist to join its Regulatory Affairs team. This is an excellent opportunity to be part of a growing, multinational organisation with a diverse portfolio of medical devices marketed globally.
As a Regulatory Specialist, you will play a key role in supporting global product registrations and maintaining technical documentation across multiple jurisdictions. Working closely with cross-functional teams including R&D, Quality, Operations, and Supply Chain, you will help ensure products meet applicable regulatory and standards requirements throughout their lifecycle.
Key Responsibilities- Ownership and maintenance of technical files for medical devices across key global markets
- Preparation and generation of regulatory documentation, including GSPR, risk management files, device descriptions, and labelling content
- Supporting EU MDR and UKCA submissions, as well as global registration activities
- Coordinating documentation to support new product development (NPD) and change activities
- Identifying applicable standards and testing requirements and proposing compliance strategies
- Leading label creation and template development, supporting multi-site labelling projects
- Supporting regulatory-related quality plans, economic operator agreements, and internal/external documentation requests
- Maintaining regulatory logs, databases, and submission trackers
- Monitoring regulatory and standards updates and assessing potential business impact
To be successful in this role, you will demonstrate:
- A degree (or equivalent) in a scientific or engineering discipline
- 3-5 years of experience in Regulatory Affairs within the medical device industry
- Working knowledge of EU MDR (2017/745) and UK MDR 2002 (as amended)
- Familiarity with ISO 13485 and ISO 14971
- Strong written and verbal communication skills
- Ability to work independently while contributing effectively within a cross-functional team
- Proficiency with documentation tools such as Microsoft Word, Excel, PowerPoint, and Adobe
- Participation in internal or external audits
- Exposure to FDA submissions, MDSAP countries, or global regulatory systems
- Experience supporting international product registrations
This role offers the chance to develop your regulatory career within a supportive and collaborative RAQA team, contributing directly to the safe and compliant delivery of medical devices used by patients worldwide.
Regulatory Affairs Specialist in Cardiff employer: Walker Cole International
Contact Detail:
Walker Cole International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist in Cardiff
✨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 EU MDR and UKCA regulations. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise.
✨Tip Number 3
Showcase your experience with technical documentation and regulatory submissions during interviews. We suggest bringing examples of your work or discussing specific projects to highlight your skills and contributions.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Affairs Specialist in Cardiff
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Specialist role. Highlight your experience in medical devices and any relevant regulatory knowledge, especially around EU MDR and UKCA. We want to see how your background fits with what we do!
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 skills can contribute to our team. Be specific about your experience with technical documentation and product registrations.
Showcase Your Communication Skills: Since strong written communication is key for this role, make sure your application is clear and concise. We love candidates who can convey complex information simply, so don’t hesitate to demonstrate this in your writing!
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 shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Walker Cole International
✨Know Your Regulations
Make sure you brush up on the EU MDR and UK MDR regulations before your interview. Being able to discuss these frameworks confidently will show that you’re not just familiar with them, but that you can apply this knowledge practically in your role.
✨Showcase Your Documentation Skills
Prepare examples of regulatory documentation you've worked on, like GSPR or risk management files. Bring along samples if possible, as this will demonstrate your hands-on experience and attention to detail, which are crucial for a Regulatory Affairs Specialist.
✨Cross-Functional Collaboration
Be ready to talk about your experience working with different teams, such as R&D and Quality. Highlight specific projects where you collaborated effectively, as this role requires strong teamwork skills to ensure compliance across various departments.
✨Stay Updated on Industry Changes
Research recent updates in regulatory standards and how they might impact the medical device industry. Showing that you’re proactive about staying informed will impress interviewers and demonstrate your commitment to the field.
