Principal TPM, SaMD

Job Summary

A company is looking for a Principal TPM, SaMD (Remote).

Key Responsibilities

• Lead planning and delivery of SaMD programs, ensuring compliance with software lifecycle processes and healthcare software safety standards
• Collaborate with cross-functional teams to align on regulatory, quality, and engineering needs for medical device software solutions
• Define and govern SDLC processes for SaMD development, integrating compliance controls and automation strategies

Required Qualifications

• Bachelor's degree in Computer Science, Engineering, or a related technical field
• 10+ years of experience in technical program management, specifically in regulated environments
• Experience with SaMD and knowledge of IEC 62304, IEC 82304, ISO 13485, and ISO 14971
• Proven ability to translate regulatory requirements into technical workflows and automated compliance mechanisms
• Strong leadership experience in driving cross-functional initiatives