RC-REGULATORY COMPLIANCE-CSV-Quality Lead -SaMD-Senior

The opportunity

We are seeking a highly experienced and detail oriented SaMD GxP Quality Consultant with strong expertise in Software as a Medical Device (SaMD) quality governance, validation, and regulatory compliance within GxP regulated and quality critical environments. The ideal candidate will ensure the safety, reliability, integrity, and regulatory readiness of SaMD solutions while partnering with cross functional teams to establish, implement, and sustain inspection ready, compliant digital health systems.

This role is responsible for leading SaMD quality and validation activities across the full product lifecycle, including requirements definition, risk management, design controls, validation planning, deployment readiness, and post market change management, in alignment with GxP principles, risk based validation, and data integrity expectations. In addition, the consultant will own and manage SaMD lifecycle documentation and templates, including...