• Support the development and execution of regulatory strategies to ensure FDA authorization and global compliance for IVD and Software as a Medical Device (SaMD) products. • Prepare and contribute to regulatory submissions, including FDA pre-submissions, 510(k), De Novo, and EU IVDR Technical Documentation. • Collaborate with cross-functional teams to ensure regulatory requirements are integrated throughout the product lifecycle. • Provide regulatory input during design and development activities, including risk management, change control, verification/validation, and labeling. • Monitor and interpret evolving regulatory requirements and standards (e.g., ISO 13485, ISO 14971, IEC 62304, IEC 62366) and assess impact on product development and compliance. • Support internal audits and regulatory inspections, including preparation of documentation and development of CAPAs related to regulatory findings. • Deliver regulatory training and guidance to internal teams to support ongoing compliance and foster a strong quality and regulatory culture. • Contribute to continuous improvement initiatives within the Regulatory Affairs function.