Regulatory Affairs Engineer – Medical Devices

Overview

In this role you integrate regulatory thinking with engineering to support a diverse portfolio of complex projects in Cambridge. You’ll work closely with design engineers, scientists and project teams to ensure development pathways align with regulatory requirements from concept through release. You will influence product architecture, design decisions and verification strategies by applying standards like ISO 9001, ISO 13485 and FDA 21 CFR 820. This fast-paced, collaborative role sits within a quality and regulatory function that operates alongside technical teams to enable innovation and timely market access.

Responsibilities

• Provide hands-on regulatory support across multiple projects
• Contribute to operation and continuous improvement of the quality management system
• Track changes in international regulations and interpret their impact for engineering teams
• Communicate clear, actionable regulatory guidance to multidisciplinary colleagues
• Support internal improvement initiatives and external audit preparation
• Help maintain regulatory processes that are practical for real-world development
• Assist in shaping design controls and downstream processes across the product lifecycle

Key requirements

• Experience in regulatory engineering within the medical device sector
• Ability to interpret technical requirements and relate them to design, verification and manufacturing
• Strong communication and relationship-building skills with design engineers and cross-functional teams
• Degree in engineering or science (relevant field)
• Proven contribution to regulatory strategies and lifecycle understanding

• Excellent communication
• Cross-functional collaboration
• Analytical thinking
• Regulatory strategy development
• Knowledge of ISO 9001, ISO 13485 and FDA 21 CFR 820
• Design controls and regulatory interpretation

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