Compliance Process Architect - Healthcare Technology SDLC

** Job Description*
* 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.

Within our Healthcare Compliance Team, the Compliance Process Architect - Healthcare SDLC, is responsible for Interpreting and translating healthcare software regulations/standards (IEC 62304, ISO 14971, ISO 13485, 21 CFR 820/11, etc. as applicable) into concrete SDLC policies, SOPs, WIs, and templates. The Compliance Process Architect - Healthcare SDLC will be responsible for designing, optimizing, and governing software development processes to deliver high-quality, compliant, and effective healthcare technology solutions.

This role collaborates with engineering and compliance teams to ensure process efficiency, regulatory alignment, and continuous improvement throughout the software development lifecycle (SDLC).

We are looking for someone with demonstrated awareness of regulatory standards and hands-on experience integrating regulatory requirements into all phases of the software development lifecycle. The ideal candidate will possess strong communication skills, a proven ability to learn quickly, and thrive in a dynamic environment. Excellent project management, compliance expertise, and communication abilities are essential for success in this role.

You will play a key role in providing strong focus on process standardization, policy creation, and continuous education to ensure that processes are consistently followed and optimized. Additional responsibilities will include, but are not limited to, collaborating with cross-functional teams to implement new processes, contributing to broad cross-functional projects and initiatives, and identifying process gaps and developing solutions to improve the overall effectiveness of processes.

If you're out to change the world in ways that matter, we want to hear from you. As a member of our team, you will be joining an inclusive, social, and innovative workplace that has a strong emphasis on developing talent and promotion from within.

Responsibilities

Responsibilities of a Compliance Process Architect - Healthcare SDLC will include, but are not limited to

-    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 healthcare 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.

** Responsibilities*
* Qualifications

-    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.

-    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.

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