25 regulatory compliance internal audit jobs found in Juneau, AK

Job Description In this highly visible leadership position, you will drive programs that integrate SaMD regulatory requirements into engineering workflows, SDLC practices, release processes, and cloud delivery models. You will partner closely with Engineering, Product, Quality, Regulatory, Clinical, Security, and Compliance teams to ensure Oracle's healthcare solutions align with global medical device standards, including IEC 62304, IEC 82304, ISO 13485, ISO 14971 , and related IMDRF SaMD guidance. You will own cross-organization planning, execution, and delivery accountability for SaMD initiatives-translating regulatory requirements into actionable engineering backlogs, creating scalable quality system processes, and enabling automation for audit readiness. Your work will ensure our software development practices meet the expectations for medical device safety, risk management, usability, security, and post-market surveillance. Key Responsibilities SaMD Program...

The Training COE will lead the creation and execution of a Center of Excellence (CoE) for GxP & non-GXP learning and development. The role will oversee a global team dedicated to designing and delivering best-in-class training programs in GxP compliance, Ethics & Compliance, and Pharmacovigilance, ensuring alignment with regulatory requirements and business objectives. This strategic leader will be responsible for transforming the employee training experience by driving innovation, standardization, and operational efficiency across the organization. Key Responsibilities Establish and lead a Global Learning & Development Center of Excellence, setting the vision, strategy, and governance for enterprise training programs. Design and implement a modern, scalable, and engaging training ecosystem that enhances employee learning experiences and supports regulatory compliance. Oversee the development and global deployment of training programs in:...

The Director, GxP Training Lead, is a senior leader within the Learning Center of Excellence under Global Quality. This role is responsible for developing and executing the global GxP training strategy to ensure compliance with regulatory requirements and foster a strong quality culture across the organization. The position provides strategic oversight for training governance, program design, and operational excellence, enabling the organization to meet inspection readiness and continuous improvement goals. Key Responsibilities: Strategic Leadership & Governance Define and lead the global GxP training strategy aligned with corporate quality objectives and regulatory standards. Establish governance frameworks for training compliance, including policies, SOPs, and audit readiness. Serve as the primary training authority during regulatory inspections and internal audits. Program Development & Delivery Design and oversee GxP training...

Director, Training Management Operations Lead The Director, Training Management Operations Lead, is a senior leader within the Learning Center of Excellence (CoE) under Global Quality. This role is responsible for overseeing the end-to-end management of global training operations, ensuring compliance with regulatory requirements, operational efficiency, and alignment with corporate quality objectives. The position drives governance, technology enablement, and process optimization for training systems and programs across GxP and non-GxP functions. Key Responsibilities: Strategic Leadership & Governance Define and execute the global training operations strategy within the Learning CoE to support quality and compliance objectives. Establish governance frameworks for training management, including policies, SOPs, and audit readiness. Serve as the primary point of contact for training operations during regulatory inspections and internal audits....

Job Description About the Role Oracle Health Data Intelligence (HDI) is entering a critical phase of regulatory and security modernization across our global health analytics and AI-enabled population health platform. As HDI accelerates readiness for MDR (Medical Device Regulation), AI regulatory requirements, and emerging global security standards, we are expanding our Security Architecture team with specialists who bring deep technical expertise, cloud security experience, and strong regulatory awareness. We are hiring Security Architecture Specialists who can design, review, and validate secure architectures across cloud-native healthcare systems, AI/ML pipelines, and distributed data platforms. This role is ideal for someone with experience performing CSSAP-style reviews , cloud security assessments, threat modeling, and providing technical guidance that aligns engineering execution with security and regulatory expectations. You will play a key role in ensuring...

Job Description About the Role Oracle Health Data Intelligence is entering a high-impact phase of MDR (Medical Device Regulation) readiness and regulatory transformation . Over the next year, HDI must execute a large volume of technical documentation, risk management activities, and engineering design updates required for compliance across our AI-enabled population health platform. To support these efforts, we are hiring Regulatory Technical Documentation Engineers with deep engineering backgrounds , strong technical writing skills, and experience in hyperscaler-style environments (cloud-native, large-scale distributed systems, secure compute, data pipelines). These engineers will be dedicated to MDR documentation, risk management updates, and regulatory alignment-removing this burden from engineering leaders and accelerating our compliance timelines. Career Level - IC4 Responsibilities What You Will Do In this role, you will be responsible for...

Job Description About the Role Oracle Health Data Intelligence is entering a high-impact phase of MDR (Medical Device Regulation) readiness and regulatory transformation . Over the next year, HDI must execute a large volume of technical documentation, risk management activities, and engineering design updates required for compliance across our AI-enabled population health platform. To support these efforts, we are hiring Regulatory Technical Documentation Engineers with deep engineering backgrounds , strong technical writing skills, and experience in hyperscaler-style environments (cloud-native, large-scale distributed systems, secure compute, data pipelines). These engineers will be dedicated to MDR documentation, risk management updates, and regulatory alignment-removing this burden from engineering leaders and accelerating our compliance timelines. Career Level - IC4 Responsibilities What You Will Do In this role, you will be responsible for...

Job Description About the Role Oracle Health Data Intelligence is entering a high-impact phase of MDR (Medical Device Regulation) readiness and regulatory transformation . Over the next year, HDI must execute a large volume of technical documentation, risk management activities, and engineering design updates required for compliance across our AI-enabled population health platform. To support these efforts, we are hiring Regulatory Technical Documentation Engineers with deep engineering backgrounds , strong technical writing skills, and experience in hyperscaler-style environments (cloud-native, large-scale distributed systems, secure compute, data pipelines). These engineers will be dedicated to MDR documentation, risk management updates, and regulatory alignment-removing this burden from engineering leaders and accelerating our compliance timelines. Career Level - IC5 Responsibilities What You Will Do In this role, you will be responsible for...

Job Description Oracle Cloud Infrastructure (OCI) is building the next generation cloud to support demanding hyperscale and AI/ML workloads. The Cloud Compliance & Assurance org are the keepers of customer trust at OCI. We ensure that Oracle Cloud IaaS, PaaS, and SaaS services meet the high compliance standards that our customers expect. We are looking for a driven, curious, and collaborative technical professional with a track record of raising the bar on the security and compliance of complex cloud and AI/ML services. You will work with subject matter experts across Oracle to help define the security, compliance, and operational standards we should follow. You will work with engineering teams and ensure that our infrastructure and IaaS, PaaS, and SaaS services meet these standards. You will be expected to have deep expertise in cloud services, AI/ML compliance, cloud compliance, and/or security. By leveraging this unique cross-section of skills, you will guide...

Job Description About the Role Oracle Health Data Intelligence (HDI) is entering a critical phase of regulatory and security modernization across our global health analytics and AI-enabled population health platform. As HDI accelerates readiness for MDR (Medical Device Regulation), AI regulatory requirements, and emerging global security standards, we are expanding our Security Architecture team with specialists who bring deep technical expertise, cloud security experience, and strong regulatory awareness. We are hiring Security Architecture Specialists who can design, review, and validate secure architectures across cloud-native healthcare systems, AI/ML pipelines, and distributed data platforms. This role is ideal for someone with experience performing CSSAP-style reviews , cloud security assessments, threat modeling, and providing technical guidance that aligns engineering execution with security and regulatory expectations. You will play a key role in ensuring...

Job Description About the Role Oracle Health Data Intelligence is entering a high-impact phase of MDR (Medical Device Regulation) readiness and regulatory transformation . Over the next year, HDI must execute a large volume of technical documentation, risk management activities, and engineering design updates required for compliance across our AI-enabled population health platform. To support these efforts, we are hiring Regulatory Technical Documentation Engineers with deep engineering backgrounds , strong technical writing skills, and experience in hyperscaler-style environments (cloud-native, large-scale distributed systems, secure compute, data pipelines). These engineers will be dedicated to MDR documentation, risk management updates, and regulatory alignment-removing this burden from engineering leaders and accelerating our compliance timelines. Career Level - IC3 Responsibilities What You Will Do In this role, you will be responsible for...

Job Description Manages the ongoing preparation, testing, and monitoring of compliance with information security standards and government regulations and regulatory agencies as it relates to the design, development, and deployment of products and services. Qualifications 15+ years experience 5+ years experience with FedRAMP at a hyper-scale cloud service provider, or as a FedRAMP 3PAO 5+ years experience leading or managing teams Strong knowledge of US Government Risk Management Frameworks and authorization processes, such as FedRAMP, DoD Cloud SRG, ICDs, NIST, DIACAP, JSIG, NISPOM Strong knowledge and ability to demonstrate interpretation and analysis of security controls Strong knowledge of security standards and risk management Excellent written and verbal communication skills. Preferred Qualifications Eligibility for TS/SCI Government security clearance BA/BS or advanced degree CISA, CISM, CISSP, CIPP...

Job Description While much of the focus of this role will revolve around delivery cloud database security and related technologies, a large portion of the work will also involve adjacencies including securing and configuring tenancies, networking, encryption and key or Certificate Management, Web Application Firewalls, SIEM technologies, vulnerability scanning, DB Security, Penetration Testing, Compliance and Security Assessment etc. Primarily interacting directly with customers, the role involves regular work with the development organization to drive product improvements and innovations. This is a senior technical Cloud Delivery role, so the Cloud technical experience in Security is the higher priority. A Cloud Architect in our team is responsible for successful implementation of non-routine and complex business solutions ensuring Security, quality and timely delivery within budget to the customers' happiness. Analyze business needs to help ensure Oracle's solution meets...

Job Description Senior Director of Program Management - Security, Compliance & Strategic Programs Oracle Health Applications & Infrastructure (OHAI) Oracle Health Applications & Infrastructure (OHAI) is seeking a highly strategic and influential Senior Director of Program Management to lead enterprise-wide Security, Compliance, and cross-organizational strategic programs. This leader will operate as a senior advisor, execution driver, and integrator across eight major product lines and ~6,000 engineers. The successful candidate will own high-stakes initiatives tied to release governance, OHRM maturity, audit readiness, and the transition to a monthly release model. The role partners closely with executives, engineering leadership, Security, Compliance, Product, and cross-functional stakeholders to ensure operational excellence at scale. Key Responsibilities Lead Enterprise Security, Compliance & Release Governance Own end-to-end...

Company : Highmark Inc. Job Description : JOB SUMMARY This job manages the development and execution of short-term and long-term objectives to standardize business practices and enhance system applications. Actively participates in and leads projects. Develops and implements appropriate controls and processing methods and manage adherence to. Manages staff responsible for addressing daily system and process issues. Provides leadership in the development, implementation, management and accurate maintenance of all contractually-based producer arrangements. Establishes and maintain all operational and system processes across the organization to support producer arrangements. This role can be remote or hybrid - If you are within 50 miles of an office you are required to be onsite 3 days a week - T, W, Th. ESSENTIAL RESPONSIBILITIES Perform management responsibilities to include, but are not limited to: involved in hiring and termination decisions, coaching...

Become a part of our caring community and help us put health first The Network Operations Coordinator 4 maintains provider relations to support customer service activities through data integrity management and gathering of provider data needed for service operations. The Network Operations Coordinator 4 assumes ownership and leads advanced and highly specialized administrative/operational/customer support duties that require independent initiative and judgment. The Network Operations Coordinator 4 manages provider data for health plans including but not limited to demographics, rates, and contract intent. Operates within fast-paced environment with ability to manage and meet strict regulatory deadlines. Manages provider audits, provider service and relations, credentialing, and contract management systems. Executes processes for intake and manage provider perceived service failures. Decisions are regarding the daily priorities for an administrative work group and/or...

Special Assignment: People Policy & Integrity At WelbeHealth, we serve our communities' most vulnerable seniors through shared intention, pioneering spirit, and the courage to love. These core values and our participant-focus lead the way no matter what. The Director, People Policy & Integrity leads WelbeHealth's employment compliance, policy governance, and risk mitigation strategy. This role oversees People policies, the Team Member Handbook, HR compliance and reporting, leave management, and workers' compensation, as well as partners with Legal, Compliance, and Quality teams on all People-related regulatory requirements, including PACE-specific oversight from DHCS and CMS. The Director, People Policy & Integrity designs and improves the team member experience across these programs, balancing day-to-day compliance with long-term enhancements. This role analyzes and presents data to drive decisions, ensure readiness for audits, and support continuous...

Job Description Oracle Clinical AI Assistant (CAA) allows providers and their support staff to focus more on patient care by reducing administrative burden of clinical and reimbursement tasks such as charting, documentation, and coding by applying power of generative AI. Our diverse team of creators and inventors are building the future of conversational clinical interfaces, making real improvements in the lives of people across the world. We act with the speed and attitude of a start-up, but with the scale and customer focus of the world's leading enterprise software company. We have a big charter and a lot of creative freedom to get it done. Come join us and grow your career in this exciting arena. We are looking for a Senior Claims Denial Prevention and Appeals Specialist for providing clinical inputs to engineering for developing the Claim Denial Prevention and Appeals features of Oracle Health Clinical AI Agent (CAA). This role leverages expert clinical judgment and...

Job Summary The Associate Director, Global Product Quality - GMP Process is responsible for enabling the optimization and harmonization of key GMP quality practices across the global organization. This role defines, maintains continuously improves critical quality system elements including Product Quality Complaints (PQC), Corrective and Preventive Actions (CAPA), Deviations, and Change Control , ensuring compliance with global regulatory requirements and internal standards. The successful candidate will lead cross-functional initiatives to enhance quality performance, reduce risk, and foster a culture of continuous improvement. Key Responsibilities Process Ownership & Governance:Lead the global strategy and governance for Product Quality Complaints, CAPA, Deviations, and Change Control processes. Develop and implement global standards, procedures, and best practices to ensure consistency and compliance across all global affiliates. Partner with regional and...

Job Description The Investigations Manager, General Investigations (IC-4) plays a critical role in protecting Oracle's employees, property, assets, and business resiliency by leading and conducting thorough investigations across North America. This position is responsible for, but not limited to, managing and executing investigations related to security breaches, loss/theft of information storage devices, the loss/theft of information, insider threat, the loss/theft of all other items (personal effects, vehicles, Oracle property, etc.), policy violations, violence (assaults and threats), workplace civility issues, and other incidents that may present security risks to the organization. The investigator will interact with executives and high-level leaders on a daily basis. The Investigations Manager should have a strong knowledge of information protection, data security, and confidential investigations. The role engages closely with stakeholders across other Lines of Business,...

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 Compliance 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...

Procurement Manager - Remote PST Job ID 250490 Posted 02-Dec-2025 Service line GWS Segment Role type Full-time Areas of Interest Accounting/Finance, Purchasing/Procurement Location(s) Remote - US - Remote - US - United States of America, Seattle - Washington - United States of America CBRE Global Workplace Solutions (GWS) works with clients to make real estate a significant contributor to organizational productivity and performance. Our account management model is at the heart of our client-centric approach to delivering integrated real estate solutions. Each client is entrusted with a dedicated leader and is supported by regional and global resources, demonstrating the industry's most robust platform. CBRE GWS delivers consistent, measurably superior outcomes for our clients at every stage of the lifecycle, and across industries and geographies. About the role: As a CBRE Procurement Manager, you'll be responsible for sourcing, negotiating, and...

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. Job Description Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. Responsible...

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in...