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Job description

At Randox, we have opportunities for applicants with strong attention to detail to join us as Graduate Technical Writers, this role will sit within our Quality Assurance/Regulatory Department, based at Randox Science Park site in Antrim. To collate and extract data and information to generate technical files which comply with regulatory guidelines..

Responsibilities

• To collate and extract data and information to generate technical files which comply with regulatory guidelines.
• To review, interpret and prepare technical reports for the regulatory technical files.
• Work closely with the regulatory team to complete and maintain technical files and medical device files.
• Work closely with R&D, manufacturing and engineering teams to obtain the required information for the technical reports and files.
• Generate technical files for the IVD products which comply with the regulatory guidelines.
• Perform detailed reviews of the technical files to ensure consistency.
• Update technical files, if and when required following changes and after annual reviews.
• Work with the QA& regulatory teams to ensure regulatory compliance and licences are maintained.

Skills and Qualifications

Essential Skills

• Educated to Degree level or relevant experience.
• Excellent communication skills (verbal and written).
• Ability to disseminate information in a concise manner.
• Ability to work methodically and reliability under pressure.
• Excellent attention to detail and report writing skills.
• Ability to interpret analytical data.

Desirable Skills

• Experience of working in a highly regulated industry.
• Experience in preparing technical files.
• Experience in a controlled manufacturing of analytical environment.

Further Information

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