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.
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