Compliance Process Architect - Healthcare Technology SDLC

at Oracle in Topeka, Kansas, United States

In Oracle Health, we are at the intersection of healthcare and IT to deliver pioneering products and services that shape the way healthcare is provided. Our best-in-class technology supports clinicians and healthcare professionals in hospitals and healthcare organizations worldwide to deliver optimal patient care. We are leading the industry in using big data intelligence to enable the shift from reactive care to proactive population level health management and are looking for a Process Architect to join us.

• 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, 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.
• Collaborate with cross‑functional teams to implement processes.
• Support continuous education to ensure processes are consistently followed and optimized.
• Monitor and analyze process performance data to identify areas for improvement and recommend corrective actions.
• Contribute to broad cross‑functional projects and initiatives.
• Support audits and regulatory reviews by maintaining up‑to‑date and accurate process documentation.
• Stay up to date with industry trends and emerging technologies to ensure processes remain effective and relevant.

• Bachelor’s degree in Business, Management or related field, or equivalent, relevant work experience.
• 7+ years of experience with at least 3 years of regulatory health care technology related work experience within a SaMD environment.
• In-depth understanding of healthcare regulations and standards relevant to software (e.g. FDA 21 CFR Part 820, ISO 13485:2016, EU MDR).
• Proven experience in process development within a healthcare software development environment.
• Strong knowledge of software development processes and quality management systems.
• Exceptional verbal and written communication and facilitation skills.
• Ability to operate effectively in a dynamic, fast‑paced, and regulated environment.

Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.

US:
Hiring Range in USD from: $90,100 to $199,500 per annum. May be eligible for bonus and equity.

• Medical, dental, and vision insurance, including expert medical opinion.
• Short term disability and long term disability.
• Life insurance and AD&D.
• Health care and dependent care Flexible Spending Accounts.
• Pre‑tax commuter and parking benefits.
• 401(k) Savings and Investment Plan with company match.
• Paid time off:
  Flexible Vacation is provided to all eligible employees assigned to a salaried (non‑overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment.
  
  Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
• 11 paid holidays.
• Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
• Paid parental leave.
• Adoption assistance.
• Employee Stock Purchase Plan.
• Financial planning and group legal.
• Voluntary benefits including auto, homeowner and pet insurance.