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- Tasks: Support regulatory compliance and monitor updates in healthcare regulations.
- Company: Join Randox, a leading global diagnostics company making a real impact on healthcare.
- Benefits: Enjoy a full-time role with a four-day work week and opportunities for growth.
- Why this job: Be part of a team that improves health worldwide and contributes to innovative solutions.
- Qualifications: Degree in Science or Engineering, strong IT skills, and experience in regulated industries required.
- Other info: Randox is an Equal Opportunities Employer, welcoming diverse talent.
The predicted salary is between 30000 - 42000 £ per year.
Randox Laboratories continues to develop disruptive innovations within the Diagnostics and Healthcare sector globally. We are proud to have been named the Number 1 company in Northern Ireland, for the second consecutive year in the "Belfast Telegraph Top 100 Companies 2024". Our staff are at the heart of everything we do and achieve. We have an exciting career opportunity for a Regulatory Affairs Specialist within our regulatory affairs team.
Location: Randox Science Park, 30 Randalstown Rd, Antrim, BT41 4FL.
Contract Offered: Full-time, Permanent.
Working Hours / Shifts: 40 hours over four days per week: Monday to Thursday, 8am to 6.40pm.
What does this role involve?
- The main function of this role is to provide regulatory support to ensure compliance with all relevant regulations.
- Review websites on a regular basis to monitor updates to regulations and standards and to ensure any new relevant publications are purchased and reviewed.
- Review new / updated publications and summarise impact to the company.
- Present new publications to the Impact Assessment Team, take minutes of the Impact Assessment meeting and track actions from the meeting.
- Ensure regulatory procedures comply with all applicable regulatory regulations and harmonised standards.
- Advise teams of updates to regulations and advise them what is required.
- Maintain the library of regulations and standards.
- Assist with the preparation and update of regulatory assessments for new devices.
- Work with relevant departments to maintain the life-cycle of documents for Randox Products.
- Perform detailed format reviews of the technical files to ensure consistency.
- Perform annual reviews of technical files and medical device files.
- Review and approval of product labelling (IFU, labels).
- Provide regulatory support for customers, distributors and OEM partners.
- Work with the QA & Regulatory teams to ensure regulatory compliance and licenses are maintained.
Who can apply?
- Educated to degree level in a Science or Engineering related discipline, or relevant experience.
- Strong IT skills, including the use of Microsoft Office packages.
- Experience with interpretation of technical information and performance data.
- Experience in a controlled manufacturing or analytical environment.
- Experience of working in a highly regulated industry e.g. ISO13485, IVDR 2017/746, or similar standards.
- Experience in preparing technical files.
- Experience in registering IVD products and CDx products in US, Europe, China and Japan.
Randox Laboratories Limited is an Equal Opportunities Employer.
Regulatory Affairs Specialist employer: Randox
Contact Detail:
Randox Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Familiarise yourself with the latest regulations and standards relevant to the diagnostics and healthcare sector. This will not only help you in interviews but also demonstrate your proactive approach to staying updated in a highly regulated industry.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with IVD products. Engaging with industry experts can provide valuable insights and may even lead to referrals or recommendations for the role.
✨Tip Number 3
Prepare to discuss specific examples of how you've ensured compliance in previous roles. Highlighting your experience with technical files and regulatory assessments will show that you have the practical skills needed for this position.
✨Tip Number 4
Research Randox's recent projects and innovations in the diagnostics field. Being knowledgeable about their work will allow you to tailor your conversation during interviews and show your genuine interest in contributing to their mission.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Regulatory Affairs Specialist. Familiarise yourself with the key duties mentioned in the job description, such as compliance with regulations and summarising impacts of new publications.
Tailor Your CV: Customise your CV to highlight relevant experience and skills that align with the job requirements. Emphasise your educational background in Science or Engineering, and any experience in regulated industries like ISO13485 or IVDR.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the industry. Mention specific experiences that demonstrate your ability to interpret technical information and work in a controlled environment.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Randox
✨Know Your Regulations
Familiarise yourself with the key regulations and standards relevant to the role, such as ISO13485 and IVDR. Be prepared to discuss how these regulations impact the work of a Regulatory Affairs Specialist.
✨Demonstrate Technical Knowledge
Showcase your understanding of technical files and the process of registering IVD products. Bring examples from your past experience that highlight your ability to interpret technical information and performance data.
✨Prepare for Scenario Questions
Expect scenario-based questions where you may need to demonstrate how you would handle regulatory updates or compliance issues. Think through potential challenges and how you would address them effectively.
✨Highlight Team Collaboration Skills
Emphasise your ability to work with cross-functional teams, especially in a highly regulated environment. Share examples of how you've successfully collaborated with QA, engineering, or other departments to ensure compliance.
