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- Tasks: Assist with product registrations globally and ensure compliance with regulations.
- Company: Join Randox Laboratories, a top innovator in Diagnostics and Healthcare.
- Benefits: Enjoy a full-time role with a four-day work week and competitive perks.
- Why this job: Be part of a dynamic team making a real impact in healthcare.
- Qualifications: Degree in Science or Engineering, strong IT skills, and relevant experience required.
- Other info: Opportunity to work in a highly regulated industry with global reach.
The predicted salary is between 36000 - 60000 £ 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 Product Registration Officer 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 assist with national and international product registrations for Randox products.
- Assist with all requirements of registering the Randox product line directly in Europe, Brazil, Canada, China, Saudi Arabia, Australia, Malaysia, South Korea and USA etc.
- Prepare regulatory documentation, review and interpret previous regulatory documents, technical information and performance data to ensure compliance with national/international regulations and standards.
- Compile, submit and follow up on registration files to obtain and maintain marketing authorisations for IVD Medical Devices and to manage them throughout the life-cycle and respond to questions from the various regulatory authorities.
- Support the Technical writers with updating technical files.
- Assisting with the IVDR CE marking process.
- Provide regulatory support when required and ensure that customers, distributor and OEM partners are serviced at the highest level of satisfaction through quality service and quick responses.
- Coordinate the legalisation of registration documents.
- Prepare regulatory assessments for new products and assess the impact of changes on current registration.
- Perform detailed format reviews of the technical files to ensure consistency.
- 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?
Essential criteria:
- 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.
Desirable:
- 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.
- Knowledge of In vitro diagnostics (IVD) devices.
This advert may be open for as long as 30 days although we may close the advert early if we receive sufficient applicants to fill the roles.
Product Registration Officer employer: Randox
Contact Detail:
Randox Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Product Registration Officer
✨Tip Number 1
Familiarise yourself with the specific regulations and standards related to IVD products in the regions mentioned in the job description. Understanding the nuances of these regulations will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with product registrations in the healthcare sector. Engaging with industry experts can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss your technical skills in detail, particularly your experience with Microsoft Office and any relevant software used in regulatory documentation. Being able to articulate your proficiency will set you apart from other candidates.
✨Tip Number 4
Research Randox Laboratories and their product line thoroughly. Understanding their innovations and market position will allow you to tailor your responses during interviews and show that you're genuinely interested in contributing to their success.
We think you need these skills to ace Product Registration Officer
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the responsibilities and requirements of the Product Registration Officer position. Tailor your application to highlight relevant experiences and skills that align with these duties.
Highlight Relevant Experience: In your CV and cover letter, emphasise any experience you have in regulatory affairs, particularly in the diagnostics or healthcare sector. Mention specific projects or roles where you dealt with product registrations or compliance with regulations.
Showcase Technical Skills: Make sure to detail your IT skills, especially your proficiency with Microsoft Office. If you have experience interpreting technical information or working with regulatory documents, be sure to include this in your application.
Craft a Strong Cover Letter: Write a compelling cover letter that not only introduces yourself but also explains why you are a great fit for the role. Use specific examples from your past work to demonstrate your understanding of the regulatory landscape and your ability to manage product registrations.
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. Being able to discuss these in detail will show your understanding of the regulatory landscape.
✨Showcase Your Technical Skills
Be prepared to demonstrate your strong IT skills, especially with Microsoft Office. You might be asked to interpret technical information, so practice explaining complex data clearly and concisely.
✨Highlight Relevant Experience
If you have experience in a controlled manufacturing or analytical environment, make sure to mention it. Discuss any previous roles where you dealt with product registrations or compliance to showcase your suitability.
✨Prepare Questions
Have a few insightful questions ready about the company’s products and their registration processes. This shows your genuine interest in the role and helps you assess if it's the right fit for you.
