Product Registration Officer

Randox; Antrim; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading company in the Diagnostics and Healthcare sector is seeking a Product Registration Officer to support the regulatory affairs team. The successful candidate will assist with national and international product registrations, preparing documentation, and ensuring compliance with regulatory standards. Applicants should have a degree in a relevant field and strong IT skills, ideally in a regulated industry. This position offers a full-time contract and an opportunity to work in a dynamic environment.

Qualifications

• Educated to degree level in a Science or Engineering related discipline, or relevant experience.
• Strong IT skills, including Microsoft Office.
• Experience with interpretation of technical information and performance data.

Responsibilities

• Assist with product registrations for various countries.
• Prepare regulatory documentation and ensure compliance.
• Coordinate legalisation of registration documents.

Skills

Strong IT skills

Interpretation of technical information

Education

Degree level in Science or Engineering

Job description

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Product Registration Officer – (Job Ref: 25N/PRDR)

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. The main duties of the role include:

• 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.