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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 environment.
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.
- Assisting in 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 learn about potential job openings that may not be advertised.
✨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 for potential interviews by practising common questions related to regulatory affairs, particularly those focusing on ISO13485 and 21 CFR Part 820. Being able to articulate your understanding of these standards will set you apart from other candidates.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in the medical device sector, particularly any roles related to regulatory affairs. Emphasise your understanding of MDD and MDR regulations, as well as your familiarity with ISO13485.
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 will benefit Walker Cole.
Highlight Technical Skills: Clearly outline your proficiency with Microsoft Office and Acrobat Pro in your application. If you have experience with document management or ERP systems, be sure to include that as well, as it is highly relevant for this role.
Showcase Your Regulatory Knowledge: Demonstrate your understanding of regulatory frameworks by mentioning any relevant certifications or training you have completed. This could include knowledge of 21 CFR Part 820, MDD, and MDR, which are crucial for the position.
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
As a Regulatory Affairs Specialist, collaboration is crucial. Prepare examples of past experiences where you successfully worked with cross-functional teams, highlighting your communication skills and ability to support regulatory activities.
✨Demonstrate Technical Proficiency
Be ready to discuss your experience with electronic document management systems and tools like Microsoft Office and Acrobat Pro. Highlight any specific projects where you utilised these tools effectively.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world regulatory scenarios. Think of situations where you had to implement changes or support audits, and be ready to explain your approach and outcomes.
