Regulatory Affairs & Compliance Manager Healthcare

Position Overview:

Ensure our AI solution meets all UK regulatory requirements and lead the certification process for medical device approval.

Key Responsibilities:

• Navigate CE marking, UKCA, and NHS Digital Technology Assessment Criteria (DTAC) processes
• Develop and maintain our regulatory strategy and documentation
• Liaise with regulatory bodies including MHRA and NHS Digital
• Implement quality management systems compliant with ISO 13485
• Ensure GDPR compliance in data handling and processing
• Lead internal audits and prepare for external regulatory inspections

Requirements:

• 5+ years' experience in regulatory affairs for medical devices or healthcare software
• Specific experience with AI/ML medical device regulations
• Deep understanding of UK and EU medical device regulations, including post-Brexit regulatory landscape
• Experience with successful CE marking and UKCA applications
• Knowledge of GDPR and healthcare data protection requirements
• Excellent documentation and process management skills