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Job description

Randox require a Regulatory Affairs Specialist to work within our Quality Assurance/Regulatory Department based at the Randox Science Park, Antrim. 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..

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 follow up on actions from the meeting.
• Ensure regulatory and design & development procedures comply with all regulations and harmonised standards.
• Inform all 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 of new devices.
• Work with departments to maintain the life-cycle of documents for Randox Products to assess the impact of changes to regulations and the updating of technical files following the implementation of changes.
• Perform detailed format reviews of the technical files to ensure consistency.
• Perform annual reviews of technical files and medical device files
• Review and approve product labelling (IFU).
• 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
• Excellent communication skills (verbal and written) and ability to disseminate information in a concise manner
• Excellent leadership skills and a high level of self-motivation
• Ability to work methodically under pressure
• Proficient in use of Microsoft Word, Excel, PowerPoint etc
• Experience with interpretation of technical information and performance data
• Strong attention to detail
• Flexible approach and willingness to work outside hours if required

Desirable Skills

• Previous experience of working in a highly regulated industry
• Experience in preparing technical files
• Experience in a controlled manufacturing or analytical environment
• Experience in registering IVD products and CDx products in the US, Europe, China and/or Japan
• Knowledge of In Vitro diagnostics devices

Further Information

Work time: 08:40 - 17:20 to be confirmed.