- To assist with the worldwide registration of Randox Products.
- 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 for regulatory authorities.
- Work with departments to maintain the life cycle of documents for Randox Products. To assess the impact of changes to registrations and the updating of technical files following the implementation of changes.
- Creation and updating of technical files to compile with standards and assist with notifying of Competent Authorities and notified bodies.
- Perform detailed format reviews of the technical files to ensure consistency.
- Review and approval of 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.
- Coordinate the legislation of registration documents.
- 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.
- Ability to work methodically and reliably under pressure.
- Excellent attention to detail.
- Computer skills including Word, Excel, PowerPoint, Microsoft Outlook.
- Experience with interpretation of technical information and performance data.
- Flexible approach and willingness to work outside hours, if required.
- Experience of working in a highly regulated industry, e.g., ISO13485, IVDD 98/79/EC, IVDR 2017/746, 21 CFR 820 or similar standards.
- Experience in preparing technical files.
- Experience in a controlled manufacturing or analytical environment.
- Experience in registering IVD products and CDx products in US, Europe, China, and Japan.
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Product Registration Officer - Kearneysville, United States - Randox
Description
Product Registration / Accreditation Officer – Kearneysville, USA – (Job Ref: 24I/REGI)
We are currently looking to employ an experienced Product Registration Officer to work within the Quality Assurance / Regulatory Department based in Kearneysville, USA.
The Role:
The Candidate:
Essential:
Desirable:
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 Programme throughout the pandemic. In early 2020 Randox recognised the threat from COVID-19 and, based on over 40 years of diagnostic experience, quickly developed a test to accurately identify the virus.
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 calibre 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.
