Product Registration & QA Coordinator

Kearneysville, WV

Product Registration & QA Coordinator – Kearneysville, USA (Job Ref: 24I/PRKV)

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 authorizations 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: 

• 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: 

• 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.

About Randox:

An international company operating in over 145 countries that continues to have unparalleled growth, Randox Laboratories has been the heartbeat of the UK’s National COVID Testing Program throughout the pandemic. In early 2020 Randox recognized the threat from COVID-19 and, based on over 40 years of diagnostic experience, quickly developed a test to accurately identify the virus. Testing at scale commenced within weeks to support the UK’s National Testing Program and private clients alike. Through the enormous effort and commitment of its staff Randox is currently operating at a capacity of 180,000 COVID-19 samples per day, making it the most productive laboratory in the UK and Ireland and amongst the very largest in Europe.
Additionally, as a world leader in diagnostics for clinical healthcare, toxicology and food security, our expertise and product portfolio have assisted laboratories across the world in improving health and saving lives. Our global success is a result of our pioneering products and the commitment & skill of our workforce, which continue to grow exponentially.
Central to the Randox ethos is our drive and determination to improve healthcare worldwide and every one of our talented staff play a role in this. In order to serve our growing international markets, we require high caliber applicants with scientific, engineering, software, and broader business skills – including sales, marketing, logistics, finance and many more. Join the Randox team and play your part in improving the health of millions.

Randox Laboratories Limited is an Equal Opportunities Employer.