The Role
1. Ensuring regulatory compliance for existing products
2. Developing regulatory strategies for new products
3. Montior markets for updates and changes to regulations
4. Ensuring the QMS remains updated and adhering to legislation/standards
You
5. 2-4 years of professional experience in IVD Regulatory Affairs
6. Experience in regulatory submissions
7. Knowledge of FDA and FDA requirements in relation to software
8. Knowledge of IVDR Regulation 2017/746
9. Knowledge of UK Medical Device Regulation
10. Knowledge of ISO 13485, 14971, 27001 and standards IEC 62304 62375