SaMD Principal Technical Program Manager

Oracle

Confirmed live 2 days ago High trust

Quick summary

Work type
On-site
Location
Salary
$97,500–$209,500 / yr
Posted
52 days ago
Freshness
Confirmed live 2 days ago

Market check

Salary context

Below market

How this pay compares to similar roles

Similar $196k
This role $154k
$79k most similar roles pay here $266k

This role pays less than 89% of similar roles. Most pay $170,889–$222,100 — the shaded band above. At the midpoint, this role pays about $154k versus about $196k for comparable roles.

Based on 240 similar postings.

Employer

About Oracle

Oracle Corporation is a leading multinational technology company specializing in database software, cloud computing, and enterprise software.

Oracle currently has 781 open roles on FindRole.

Listed pay typically runs $102,300–$209,500 across 713 roles with salary data.

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At a glance

TL;DR · SaMD Principal Technical Program Manager

SaMD Principal Technical Program Manager serves as a key leader within the Oracle Health Applications & Infrastructure team, focusing on the development of Software as a Medical Device (SaMD) solutions. This role is responsible for leading complex, cross-functional programs that integrate regulatory requirements into engineering workflows, SDLC practices, and cloud delivery models. The individual will manage end-to-end planning, translate regulatory mandates into actionable engineering backlogs, and establish automated processes for audit readiness and traceability. Essential technical expertise includes deep knowledge of IEC 62304, IEC 82304, ISO 13485, ISO 14971, and IMDRF SaMD guidelines. The role also requires proficiency in usability engineering (IEC 62366), cybersecurity-by-design (IEC 81001-5-1, ISO/IEC 27001), and AI Management Systems (ISO/IEC 42001). The position addresses the critical challenge of ensuring medical device-class software meets global safety, risk management, and compliance standards in a cloud-native environment.

What you'll do

  • Lead end-to-end planning and delivery of SaMD programs following IEC 62304 and IEC 82304 standards.
  • Translate complex regulatory requirements into actionable engineering backlogs, documentation workflows, and change-management practices.
  • Integrate risk management, traceability, and post-market surveillance processes into standard software development life cycle activities.
  • Define and govern SDLC processes for usability, cybersecurity, and AI management systems.
  • Implement automated evidence generation and compliance controls within CI/CD pipelines.
  • Coordinate cross-functional efforts between Engineering, Product, Quality, Regulatory, and Clinical teams to ensure audit readiness.
  • Develop executive-level dashboards and reports detailing program status, risks, and mitigation strategies.

What we're looking for

  • Bachelor's degree in Computer Science, Engineering, or a related technical field.
  • Mandatory experience leading software programs governed by medical device regulations (SaMD).
  • 5 to 10+ years of experience in technical program management for complex engineering programs in regulated environments.
  • Deep understanding of IEC 62304, IEC 82304, ISO 13485, and ISO 14971 standards.
  • Ability to translate regulatory requirements into technical workflows, SDLC practices, and automated compliance mechanisms.
  • Proven leadership in coordinating cross-functional teams including engineering, regulatory, clinical, and quality stakeholders.
  • Excellent communication, technical writing, and executive presentation skills.
  • Must be a U.S. citizen willing to obtain a Public Trust clearance.

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