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Oracle · 3 months ago

Compliance Process Architect - Healthcare Technology SDLC

United States

Full-time

Remote

Senior Level

6+ years exp

Oracle Health is at the intersection of healthcare and IT, delivering pioneering products that enhance patient care. They are seeking a Compliance Process Architect - Healthcare SDLC to design and optimize software development processes, ensuring compliance with healthcare regulations while collaborating with engineering and compliance teams.

Data GovernanceData ManagementEnterprise SoftwareInformation TechnologySaaSSoftware

No H1B

Responsibilities

Interpret and translate healthcare software regulations/standards (IEC 62304, ISO 14971, ISO 13485, 21 CFR 820/11, etc. as applicable) into concrete SDLC policies, SOPs, and WIs

Author and own SDLC policy and harmonized SOP set; manage document lifecycle (draft, review, approval, periodic revalidation)

Analyze, design, and optimize software development processes for delivery of SaMD products, ensuring efficiency and compliance with healthcare regulations

Establish and maintain standardized process documentation, including workflows, standard operating procedures (SOPs), and work instructions aligned with both agile and traditional SDLC methodologies

Ensure processes align with organizational objectives, customer expectations, and industry best practices

Guide the integration of regulatory and quality requirements into software development practices and documentation

Serve as a subject matter expert on healthcare software development processes, providing guidance and training as needed

Collaborating with cross-functional teams to implement processes

Support continuous education to ensure that processes are consistently followed and optimized

Monitoring and analyzing process performance data to identify areas for improvement and recommend corrective actions

Drive continuous improvement initiatives

Contribute to broad, cross-functional projects and initiatives

Support audits and regulatory reviews by maintaining up-to-date and accurate process documentation

Staying up to date with industry trends and emerging technologies to ensure processes remain effective and relevant

Qualification

Healthcare software regulationsSDLC policiesSOPsProcess optimizationRegulatory complianceProject managementContinuous improvementTrainingGuidanceCommunication skillsCross-functional collaboration