Product Registration Officer & QA Coordinator

Randox Laboratories is currently looking to employ an experience and motivated Product Registration & Quality Assurance Coordinator to work within our QA / Regulatory Department based in Kearneysville, USA. 

The role:

• Assist with FDA registrations.
• Act as the US correspondent for Randox Laboratories.
• Prepare regulatory documentation, review, and update technical files and performance data to ensure compliance with national and international regulations and standards.
• Generate and submit registration files to obtain and maintain marketing authorisations for in-vitro diagnostic devices. Prepare and respond to questions from regulatory authorities.
• Work with sales and technical support to provide regulatory and registration support for US Customers.
• Assess the impact of changes to registrations 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 as required by regulations.
• Review and approval of product labelling to comply with US regulations (IFU, labels)
• Work with the QA & Regulatory teams to ensure regulatory compliance and licenses are maintained.
• Support Randox employees with US and Canadian regulation questions and advise on any updates to regulations.
• Maintain the Quality Management System for Randox US.
• Generate and maintain Standard Operating Procedures for the manufacturing activities based at the US facility.
• Conduct internal audits to ensure the manufacturing facility is complaint to procedures and regulations.
• Support the manufacturing department with manufacturing activities.
• Notify QA at Head Quarters of any non-conformances and help in the investigation to identify the root, cause, corrective and preventative actions.
• Support Technical Support with any customer complaints for US products.

The Candidate:
Essential criteria:

• Educated to degree level in a Science or Engineering related discipline or relevant experience.
• Excellent communication skills (written and verbal) and the ability to communicate information in a concise manner.
• Excellent leadership skills and a high level of self-motivation.
• Ability to work methodically and reliably under pressure.
• Excellent attention to detail.
• Computer skills; including proficiency with all Microsoft Office packages.
•  Experience with interpretation of technical information and performance data.
• Flexible approach and willingness to work.

Desirable criteria:

• 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.
• Knowledge of in-vitro diagnostics devices.
• This is a unique opportunity to join an innovative international company in a growing industry that can provide career security and genuine advancement opportunities for those who show potential.