Regulatory Affairs Specialist

Regulatory Affairs Specialist (Job Ref: 25N/REGS) Randox Laboratories continues to develop disruptive innovations within the Diagnostics and Healthcare sector globally. We are proud to have been named the Number 1 company in Northern Ireland, for the second consecutive year in the Belfast Telegraph Top 100 Companies 2024. Our staff are at the heart of everything we do and achieve. We have an exciting career opportunity for a Regulatory Affairs Specialistwithin our regulatory affairs team. Location: Randox Science Park, 30 Randalstown Rd, Antrim, BT41 4FL. Contract Offered: Full-time, Permanent. Working Hours / Shifts: 40 hours over four days per week: Monday to Thursday, 8am to 6.40pm. What does this role involve? The main function of this role is to provide regulatory support to ensure compliance with all relevant regulations. The main duties of the role include: 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 track actions from the meeting. Ensure regulatory procedures comply with all applicable regulatory regulations and harmonised standards. Advise 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 for new devices. Work with relevant departments to maintain the life-cycle of documents for Randox Products. Perform detailed format reviews of the technical files to ensure consistency. Perform annual reviews of technical files and medical device files. Review and approval of product labelling (IFU, labels). Provide regulatory support for customers, distributors and OEM partners. Work with the QA & Regulatory teams to ensure regulatory compliance and licenses are maintained. Who can apply? Essential criteria: Educated to degree level in a Science or Engineering related discipline, or relevant experience. Strong IT skills, including the use of Microsoft Office packages. Experience with interpretation of technical information and performance data. Desirable: Experience in a controlled manufacturing or analytical environment. Experience of working in a highly regulated industry e.g. ISO13485, IVDR 2017/746, or similar standards. Experience in preparing technical files. Experience in registering IVD products and CDx products in US, Europe, China and Japan. Knowledge of In vitro diagnostics (IVD) devices This advert may be open for as long as 30 days although we may close the advert early if we receive sufficient applicants to fill the roles. About Randox: An international company operating in over 145 countries that continues to have unparalleled growth, Randox Laboratories was at the centre of the UKs 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. Testing at scale commenced within weeks to support the UKs National Testing Programme and private clients alike. 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. Randox Laboratories Limited is an Equal Opportunities Employer.