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Regulatory affairs associate

Northwich
Permanent
Temporary
L-ev8 Recruitment Ltd
Posted: 31 January
Offer description

Regulatory Affairs Associate (12-Month FTC) – Cheshire – Up to £45,000 pa – REF 040 Hybrid Working | Full-Time Cheshire An excellent opportunity has arisen to join a global medical device manufacturing organisation as a Regulatory Affairs Associate on a 12-month fixed-term contract. The business develops and supplies innovative medical technologies used internationally and operates across the UK, Europe, the USA, and additional global markets. Following continued growth and international expansion, they are seeking additional regulatory support to manage product lifecycle activities and regulatory change across multiple territories. This role would suit a Regulatory Affairs professional with experience supporting regulatory submissions and change assessments for existing medical devices, particularly across EU, USA, and international markets. The Role: * Create, maintain, and update Regulatory Technical Documentation to ensure compliance with UKCA, EU MDR (2017/745), FDA (21 CFR Part 820), and other global regulatory requirements * Manage regulatory submissions supporting changes to existing products across EU, USA, and international territories * Maintain continued regulatory approval throughout the product lifecycle, ensuring timely updates to Technical Files and submissions * Support regulatory strategy planning and change management activities, particularly relating to product modific...

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