Healthcare Technology Compliance Architect. Job in Arlington Move Collective Jobs

In Oracle Health, we are transforming the intersection of healthcare and IT by delivering innovative products and services that shape the future of healthcare. Our advanced technology empowers clinicians and healthcare professionals across hospitals and organizations to provide exceptional patient care globally. As industry leaders leveraging big data intelligence, we are driving the shift from reactive care to proactive population health management and seeking a passionate Process Architect to join our team. As part of our Healthcare Compliance Team, the Healthcare Technology Compliance Architect is tasked with interpreting and translating vital software regulations and standards, including IEC 62304, ISO 14971, ISO 13485, and 21 CFR 820/11, into actionable policies, SOPs, and work instructions within our Software Development Lifecycle (SDLC). Your expertise will be essential in designing, optimizing, and governing our software development processes to ensure the delivery of compliant, high-quality healthcare technology solutions. We are looking for candidates with a solid understanding of regulatory standards and practical experience integrating these requirements throughout all stages of software development in a SaMD environment. The ideal candidate will demonstrate strong communication skills, a quick learning ability, and the capacity to thrive in a fast-paced environment. Effective project management, compliance knowledge, and communication skills are crucial for excelling in this role. In this position, you will focus on standardizing processes, creating robust policies, and fostering continuous education to ensure adherence to optimized procedures. Your additional responsibilities will include collaborating with cross-functional teams to implement new processes, contributing to various initiatives, identifying process gaps, and developing strategies to enhance overall process effectiveness. If you are driven to make a meaningful impact, we want to hear from you. As part of our inclusive, innovative, and socially responsible workplace, you will find ample opportunities for growth and advancement. Key Responsibilities include but are not limited to: Interpreting healthcare software regulations/standards and translating them into concrete SDLC policies, SOPs, and work instructions. Owning and authoring SDLC policy and harmonized SOP sets, including managing the document lifecycle (draft, review, approval, periodic revalidation). Analyzing and optimizing software development processes for SaMD product delivery, ensuring efficiency and regulatory compliance. Establishing and maintaining standardized process documentation aligned with both agile and traditional SDLC methodologies. Ensuring process alignment with organizational objectives and industry best practices. Guiding integration of regulatory and quality requirements into development practices and documentation. Serving as a subject matter expert on software development processes, providing necessary guidance and training. Collaborating with cross-functional teams to implement new processes effectively. Supporting continuous education initiatives to consistently uphold and refine processes. Monitoring process performance data and recommending corrective actions where necessary. Driving continuous improvement initiatives across the organization. Contributing to broad, cross-functional projects and initiatives. Assisting with audits and regulatory reviews by maintaining accurate process documentation. Staying informed about industry trends and technologies to ensure ongoing process effectiveness and relevance. Qualifications: Bachelor's degree in Business, Management, or a related field, or an equivalent combination of relevant work experience. At least 7 years of experience, with a minimum of 3 years in regulatory healthcare technology focused work 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 developing processes within a healthcare software development context. Strong knowledge of software development processes and quality management systems. Exceptional verbal and written communication and facilitation skills. Ability to thrive in a dynamic, fast-paced, and regulated environment. Required Skills: Agile Methodology Change Management Critical Thinking Detail-oriented Healthcare Regulations JIRA MS Office Problem Solving Process Improvement Project Management SDLC Strong Communication #J-18808-Ljbffr Broughton Group