Compliance Process Architect - Healthcare Technology SDLC

Oracle

Quick summary

Work type
On-site
Location
—
Salary
$90,100–$199,500 / yr
Posted
48 days ago

Market check

Salary context

Below market

How this pay compares to similar roles

Similar $186k
This role $145k
$74k most similar roles pay here $241k

This role pays less than 81% of similar roles. Most pay $155,094–$216,250 — the shaded band above. At the midpoint, this role pays about $145k versus about $186k 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 731 open roles on FindRole.

Listed pay typically runs $97,500–$209,500 across 557 roles with salary data.

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At a glance

TL;DR · Compliance Process Architect - Healthcare Technology SDLC

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As a Compliance Process Architect in Oracle Health’s Healthcare Technology SDLC team, you will interpret healthcare software regulations such as IEC 62304, ISO 14971, and FDA 21 CFR Part 820 to create concrete policies and standard operating procedures for the software development lifecycle. Your day-to-day responsibilities include designing efficient processes that ensure regulatory compliance while supporting agile and traditional SDLC methodologies. You will collaborate with engineering teams to optimize workflows, provide training on new regulations, and maintain up-to-date documentation to support audits and continuous improvement initiatives. This role requires a deep understanding of healthcare technology standards, strong project management skills, and the ability to thrive in a fast-paced environment. Ideal candidates have 7+ years of experience in regulatory health care technology, with a focus on software as a medical device (SaMD) environments.

Skills

IEC 62304 ISO 14971 ISO 13485 21 CFR 820/11 SDLC Agile Waterfall SOPs WIs Quality Management Systems FDA Regulations EU MDR Process Documentation Workflow Design Continuous Improvement Project Management Compliance Audits Training Development

What you'll do

  • Interpret and translate healthcare software regulations into concrete SDLC policies and SOPs.
  • Design and optimize software development processes for SaMD products to ensure compliance and efficiency.
  • Establish standardized process documentation aligned with both agile and traditional SDLC methodologies.
  • Guide the integration of regulatory requirements into software development practices and documentation.
  • Monitor process performance data to identify areas for improvement and recommend corrective actions.

What we're looking for

  • 7+ years of experience in healthcare technology, including at least 3 years in a SaMD environment
  • In-depth understanding of healthcare regulations such as FDA 21 CFR Part 820 and ISO standards
  • Proven experience in developing software development processes within a regulated healthcare setting
  • Strong knowledge of quality management systems and software development lifecycle methodologies
  • Excellent verbal and written communication skills for facilitating process implementation
  • Ability to operate effectively in dynamic, fast-paced, and highly regulated environments
  • Experience in guiding the integration of regulatory requirements into software development practices

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