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- Tasks: Support regulatory activities and maintain technical files in a dynamic medical device environment.
- Company: Join Walker Cole, a fast-growing medical device company with a global reach based in Northern Ireland.
- Benefits: Enjoy opportunities for professional growth and collaboration in a vibrant team culture.
- Why this job: Be part of a crucial transition in the medical field, making a real impact on healthcare.
- Qualifications: Experience in medical devices and strong communication skills are essential; familiarity with regulations is a plus.
- Other info: Ideal for those passionate about regulatory affairs and eager to learn in a supportive setting.
The predicted salary is between 36000 - 60000 £ per year.
Walker Cole is looking for a Regulatory Affairs Specialist to join an exciting fast-growing medical device company with international scope based in Northern Ireland.
As a Regulatory Affairs Specialist you will be:
- Assisting in maintenance of technical files, including creation and control of documentation.
- Supporting transition from MDD to MDR where required.
- Liaising with departments to support Regulatory activities.
- Implementing actions as directed by Regulatory Managers, including in support of Engineering Changes.
- Supporting teams during external and internal audits.
- Supporting global registration activities.
- Working with technical documentation within electronic document management systems.
A Regulatory Affairs Specialist will have:
- Experience within Medical Devices or a related area.
- Understanding of the Regulatory Profession.
- Teamwork and great oral and written communication skills.
- Experience working with Microsoft, Acrobat Pro.
Desirable skills of a Regulatory Affairs Specialist:
- Experience of ISO13485.
- Understanding of 21 CFR p820, MDD and/or MDR.
- Experience of document management and/or ERP systems.
Regulatory Affairs Specialist 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
✨Tip Number 1
Familiarise yourself with the latest updates on the Medical Device Regulation (MDR) and the transition from the Medical Device Directive (MDD). This knowledge will not only help you in interviews but also demonstrate your commitment to staying current in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience in medical devices. Attend industry conferences or webinars to make connections and gain insights that could give you an edge during the application process.
✨Tip Number 3
Brush up on your skills with Microsoft Office and Acrobat Pro, as these tools are essential for creating and managing technical documentation. Consider taking a short online course if you feel you need a refresher.
✨Tip Number 4
Prepare to discuss your teamwork and communication skills in detail. Think of specific examples where you've successfully collaborated with others, particularly in regulatory contexts, as this will be crucial for the role.
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 the medical device sector, particularly any roles related to regulatory affairs. Emphasise your understanding of MDD and MDR, as well as your familiarity with ISO13485 and 21 CFR p820.
Craft a Compelling Cover Letter: In your cover letter, explain why you are passionate about regulatory affairs in the medical device industry. Mention specific experiences that demonstrate your teamwork and communication skills, and how they relate to the responsibilities outlined in the job description.
Showcase Relevant Skills: Highlight your proficiency with Microsoft Office and Acrobat Pro in your application. If you have experience with document management or ERP systems, make sure to include that as well, as it is a desirable skill for this role.
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 regulatory affairs.
How to prepare for a job interview at Walker Cole International
✨Know Your Regulations
Familiarise yourself with the key regulations such as ISO 13485, MDD, and MDR. Be prepared to discuss how your experience aligns with these standards and how you can contribute to compliance in the role.
✨Showcase Your Teamwork Skills
Since collaboration is crucial in regulatory affairs, be ready to share examples of how you've successfully worked within a team. Highlight any specific projects where you liaised with different departments to achieve regulatory goals.
✨Demonstrate Technical Proficiency
Make sure to mention your experience with document management systems and tools like Microsoft Office and Acrobat Pro. You might be asked to explain how you've used these tools in past roles, so have some examples ready.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about challenges you've faced in regulatory affairs and how you overcame them, especially during audits or transitions between regulations.
