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Principal TPM, SaMD
Principal TPM, SaMDVirtualVocations • Lincoln, Nebraska, United States
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Principal TPM, SaMD

Principal TPM, SaMD

VirtualVocations • Lincoln, Nebraska, United States
[job_card.variable_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

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

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Principal • Lincoln, Nebraska, United States

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