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Job description

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. Please see employer website for full job details & person specification.

Responsibilities

• 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.

Skills and Qualifications

Essential Skills

• 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 Skills

• 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.