Regulatory Affairs Specialist

SciPro continues our long-standing exclusive partnership with a ground-breaking, medical device company who are the creators of an award-winning AI-powered imaging biomarkers and software solution. They are passionate about becoming a leader in the precision medicine space, enabling better treatment decisions for patients. We are supporting the company on their search for a Regulatory Affairs Specialist within the UK.

As a Regulatory Affairs Specialist, you will be responsible for supporting global regulatory activities, ensuring products remain compliant across both EU and US regulatory frameworks. Working closely with cross-functional teams, you will help drive regulatory strategy, support product lifecycle changes, and ensure regulatory requirements are embedded across the organisation.

Key Responsibilities

• Support FDA submissions, ensuring regulatory documentation is prepared accurately and delivered on time.
• Manage product changes across EU and US markets, ensuring all updates remain compliant with applicable regulatory requirements.
• Oversee post-market surveillance activities, monitoring product performance and ensuring ongoing regulatory compliance.

Key Requirements

• Experience as a Regulatory Affairs Specialist or Senior Regulatory Specialist.
• Strong understanding of regulatory compliance for SaMD or IVD products.
• Experience working within EU and/or US regulatory frameworks.