Regulatory Affairs Specialist

Sci Pro 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