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- Tasks: Support regulatory activities and maintain technical files in a dynamic medical device environment.
- Company: Join a fast-growing medical device company with an international presence based in Northern Ireland.
- Benefits: Enjoy opportunities for professional growth and collaboration in a supportive team culture.
- Why this job: Be part of a vital industry, making a difference in healthcare while developing your skills.
- 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 thriving sector.
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 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 online courses if you feel you need a refresher.
✨Tip Number 4
Prepare for potential interviews by practising common questions related to regulatory affairs and medical devices. Be ready to discuss your previous experiences and how they relate to the responsibilities outlined in the job description.
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. Emphasise your understanding of regulatory frameworks like MDD and MDR, as well as any specific skills related to 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, as these are crucial for the role.
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, make sure to include that as well.
Showcase Your Regulatory Knowledge: Demonstrate your understanding of the regulatory profession by mentioning any relevant certifications or training. Discuss your familiarity with 21 CFR Part 820 and how it applies to your previous roles.
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 Documentation Skills
Since the role involves maintaining technical files and working with electronic document management systems, be ready to provide examples of your past experiences with documentation. Highlight any specific tools you've used, like Microsoft or Acrobat Pro.
✨Demonstrate Teamwork and Communication
Regulatory Affairs Specialists often liaise with various departments. Prepare to share examples of how you've successfully collaborated with teams in the past, showcasing your oral and written communication skills.
✨Prepare for Audits
As the role includes supporting teams during audits, think about your previous experiences with internal or external audits. Be ready to discuss how you contributed to successful outcomes and what you learned from those experiences.
