Clinical Validation & Regulatory Officer

We are seeking a Clinical Validation & Regulatory Officer to support the development and commercialisation of innovative digital health products. This role will be responsible for ensuring clinical validation activities align with regulatory requirements, supporting evidence generation, and contributing to successful market access strategies.

Key Responsibilities:

• Support clinical validation and evaluation activities for regulated digital health products.
• Assist with regulatory submissions and compliance activities across relevant markets.
• Collaborate with Clinical, Quality, and Product teams to ensure regulatory and validation requirements are met.
• Maintain technical and regulatory documentation in line with applicable standards and regulations.
• Monitor evolving regulatory requirements within the HealthTech and SaMD landscape.

Ideal Background:

• Experience within HealthTech, Digital Health, Medical Devices, SaMD, or Digital Therapeutics.
• Knowledge of clinical validation, regulatory affairs, quality management systems, and compliance requirements.
• Familiarity with regulations such as MDR, UKCA, FDA, or other global frameworks.
• Strong stakeholder management and cross-functional collaboration skills.