Job Description
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 within a SaMD environment. 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 inc