Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager, SaMD & GxP, United Kingdom

We are looking for a Senior Regulatory Affairs Specialist to support the regulatory strategy and compliance activities for AI-enabled software products used within clinical and healthcare environments. This position will play a key role in ensuring products meet international regulatory and quality standards across the UK, EU and US markets.

The role will involve leading regulatory submissions and maintaining compliance for Software as a Medical Device (SaMD) and AI-based technologies, while working closely with cross-functional teams including Quality, Engineering, Product, Clinical Operations and Data Science. You will provide regulatory guidance throughout the software development lifecycle, including validation activities and risk management processes.

Key responsibilities include:

• Developing and implementing regulatory strategies for software and AI-driven medical technologies
• Supporting global regulatory submissions and interactions with notified bodies, auditors and regulatory authorities
• Ensuring compliance with relevant standards and regulations including ISO 13485, IEC 62304, ISO 14971 and AI/ML guidance
• Reviewing technical documentation, risk management files and validation documentation
• Supporting audits, inspections and quality management activities
• Monitoring regulatory developments and advising internal teams on compliance requirements

The ideal candidate will have:

• Significant experience within Regulatory Affairs focused on SaMD and AI-based healthcare technologies
• Strong knowledge of global medical device regulations and quality standards
• Experience supporting software validation and regulated development environments
• Excellent stakeholder management and cross-functional communication skills
• A degree in a scientific, engineering or technical discipline

If you are interested in finding out more, click apply now!