Regulatory and Quality Manager

The Regulatory and Quality Manager is responsible for leading and managing all regulatory affairs and quality assurance activities for Topia Medtech Limited. The role ensures that the company’s medical devices and related products comply with applicable UK, EU, and international regulatory requirements and quality standards.

The individual will develop regulatory strategies, prepare and manage submissions, coordinate approvals with regulatory authorities, maintain the Quality Management System (QMS), and support post‑market compliance activities.

Key Responsibilities

1. Regulatory Strategy & Compliance

• Develop and implement regulatory strategies for medical devices in the UK, EU, and other international markets.
• Interpret and apply regulatory requirements including:
• UK MDR 2002 (as amended)
• EU MDR 2017/745
• ISO 13485
• MHRA guidance
• Provide regulatory guidance during product develop...