Regulatory Affairs Associate

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 modifications, extensions, and manufacturing changes
  
  
• Collaborate closely with Quality, R&D, Engineering, Operations, Clinical, and Commercial teams to ensure regulatory requirements are met
  
  Skills & Experience Required:
  
  
• Degree (or equivalent) in a Life Science or related discipline
  
  
• Experience working within a regulated medical device environment
  
  
• Strong understanding of EU MDR and FDA Quality System Regulation (QSR)
  
  
• Working knowledge of ISO 13485
  
  
• Experience maintaining Technical Files and supporting regulatory submissions
  
  
• Experience assessing regulatory impact of changes to existing products (highly desirable)
  
  
• Understanding of Risk Management within medical devices
  
  This is a hands-on regulatory role within a collaborative, international organisation where regulatory expertise plays a critical role in patient safety, compliance, and product performance. The position offers exposure to global markets and a broad range of regulatory activities across the full product lifecycle.
  
  To apply for this role, please call and/or send your CV to David Hopkin