Regulatory Affairs Associate

Job description

Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Job Description: POSITION SUMMARY: We are seeking an experienced Regulatory Affairs Associate to support our Human Health and Animal Health Diagnostics Groups, specifically focused on regulatory submissions and compliance. This role is ideal for a detail-oriented professional with a strong understanding and experience of global regulatory requirements and a passion for ensuring patient safety. JOB DUTIES include but are not limited to: - Assist with preparing and review of regulatory documentation for medical devices (e.g. 510(k), CLIA Waivers and Technical Files). - Ensure compliance with FDA, EU In Vitro Diagnostic Device Regulation, and other international regulatory requirements and appropriate regula...