Healthcare Compliance Process Architect - Software Development Lifecycle

About

At Oracle Health, we are at the forefront of merging healthcare and technology to deliver innovative products and services that transform healthcare delivery. Our cutting-edge technology empowers clinicians and healthcare professionals around the globe, enhancing patient care. We are pioneers in leveraging big data to facilitate a transition from reactive care to proactive population health management and are seeking a talented Process Architect to join our team.

As part of our Healthcare Compliance Team, the Healthcare Compliance Process Architect - Software Development Lifecycle will interpret and translate healthcare software regulations and standards (such as IEC 62304, ISO 14971, ISO 13485, 21 CFR 820/11) into actionable SDLC policies, SOPs, WIs, and templates. This role will design, optimize, and govern software development processes to ensure the delivery of high-quality, compliant healthcare technology solutions. You will actively collaborate with engineering and compliance teams to promote process efficiency, regulatory alignment, and continuous enhancement throughout the software development lifecycle.

We are in search of a candidate with a strong understanding of regulatory standards, along with practical experience incorporating these requirements into each phase of the software development lifecycle within a Software as a Medical Device (SaMD) context. Exceptional communication skills, an ability to learn quickly, and a knack for thriving in a vibrant environment are essential for success in this position. Your strong project management and compliance expertise will be invaluable.

You will play a vital role in enforcing process standardization, policy development, and ongoing education to ensure consistent adherence and optimization of processes. Additional responsibilities include working alongside cross-functional teams to launch new processes, participating in expansive projects and initiatives, identifying process deficiencies, and crafting solutions to enhance overall process effectiveness.

If you are driven to make significant changes in meaningful ways, we want to hear from you. Joining our team means becoming a part of an inclusive, collaborative, and innovative workplace that values talent development and promotes from within.

Key Responsibilities

• Interpret and apply healthcare software regulations/standards into practical SDLC policies, SOPs, and WIs.
• Own and manage the SDLC policy and harmonized SOP set, overseeing the document lifecycle (drafting, review, approvals, periodic revalidation).
• Analyze, design, and enhance software development processes for SaMD product delivery, ensuring efficiency and regulatory compliance.
• Establish and maintain standardized process documentation, including workflows, SOPs, and work instructions tailored to agile and traditional SDLC methodologies.
• Ensure adherence of processes to organizational goals, customer expectations, and industry best practices.
• Lead the integration of regulatory and quality demands into software development practices and documentation.
• Act as a subject matter expert on healthcare software development processes, providing guidance and training as needed.
• Collaborate with cross-functional teams to implement effective processes.
• Facilitate continuous education initiatives to maintain process consistency and optimization.
• Monitor and analyze process performance data to identify improvement areas and recommend corrective actions.
• Advance continuous improvement initiatives.
• Contribute to broad cross-functional projects and initiatives.
• Prepare for audits and regulatory reviews by maintaining current, accurate process documentation.
• Stay informed about industry trends and emerging technologies to ensure processes remain effective and relevant.

Qualifications

• Bachelor's degree in Business, Management, or a related discipline, or equivalent relevant work experience.
• 7+ years of experience, with at least 3 years focused on regulatory healthcare technology within a SaMD environment.
• Deep understanding of healthcare regulations and standards relevant to software (e.g., FDA 21 CFR Part 820, ISO 13485:2016, EU MDR).
• Demonstrated experience in process development within a healthcare software development context.
• Strong knowledge of software development processes and quality management systems.
• Outstanding verbal and written communication and facilitation skills.
• Ability to thrive in a dynamic, fast-paced, and regulated environment.

Benefits

• Medical, dental, and vision insurance, inclusive of expert medical opinions.
• Short-term and long-term disability coverage.
• Life insurance and AD&D.
• Health care and dependent care Flexible Spending Accounts.
• 401(k) Savings and Investment Plan with company match.
• Paid time off; vacation accrual and paid sick leave policies.
• Paid parental leave and adoption assistance.
• Employee Stock Purchase Plan.
• Financial planning and group legal benefits.
• Voluntary benefits, including auto and homeowner insurance.

About Us

Oracle is uniquely positioned to harness data, infrastructure, applications, and expertise, fueling remarkable advancements in various sectors, including life-saving healthcare solutions. By integrating AI throughout our offerings, we enable our customers to realize their potential and improve lives globally.

We promote a diverse workforce where every individual has the opportunity to contribute. Our commitment to cultivating a supportive work environment is reflected in our competitive benefits and programs that encourage community involvement.

Oracle is an Equal Employment Opportunity Employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, or veteran status.