The role provides strategic regulatory guidance for Software as a Medical Device (SaMD) and algorithm-driven digital health solutions
Job Summary
The role provides strategic regulatory guidance for Software as a Medical Device (SaMD) and algorithm-driven digital health solutions.
Responsibilities include authoring global regulatory submissions such as FDA 510(k) and EU MDR Technical Documentation while ensuring product compliance.
The company fosters a diverse and inclusive culture driven by excellence that encourages individual expression and innovative ideas.
Matching Summary
The role provides strategic regulatory guidance for Software as a Medical Device (SaMD) and algorithm-driven digital health solutions.
Skills & Requirements
Must-have
Software as a Medical Device (SaMD) experience
FDA 510(k) submission authoring
EU MDR regulatory requirements knowledge
Product lifecycle regulatory strategy
Cross-functional team collaboration
Nice-to-have
AI/ML-enabled medical device experience
Agile software development environment familiarity