About The Position

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 Process Architect is 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).

Requirements

  • 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.

Responsibilities

  • Design, optimize, and govern software development processes.
  • Collaborate with engineering and compliance teams to ensure process efficiency and regulatory alignment.
  • Focus on process standardization, policy creation, and continuous education.
  • Implement new processes in collaboration with cross-functional teams.
  • Contribute to broad cross-functional projects and initiatives.
  • Identify process gaps and develop solutions to improve overall effectiveness.
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