Overview
Oracle Health is a comprehensive suite of healthcare technology solutions designed to help organizations advance patient care, improve operational efficiency, and enhance caregiver experiences. Building on Oracle’s global expertise in cloud technology, data management, and analytics, Oracle Health delivers integrated electronic health records (EHR), population health tools, and data-driven insights for hospitals, clinics, and health systems. By connecting data and workflows across the continuum of care, Oracle Health empowers providers to make informed decisions, streamline processes, and drive better health outcomes.
Role Summary
As Lead Product Regulatory Strategist, you will be responsible for analyzing healthcare laws and regulations across the EU and UK, cultivating deep expertise in the relevant legislation, associated standards, and implementation guides. You will collaborate cross-functionally to ensure comprehensive understanding of regulatory requirements and support timely alignment of Oracle Health products with applicable compliance deadlines.
Responsibilities
The Lead Product Regulatory Strategist role involves leveraging expertise in current and emerging UK and EU health regulations to evaluate and quantify their impact on Oracle Health products and customer operations. Acting as a regulatory subject matter expert, you will provide guidance to both internal teams and external stakeholders. Responsibilities include collaborating with regional SMEs to integrate regulatory insights into product design and development and partnering with regional representatives to shape strategic responses to new and existing regulatory requirements. The role also encompasses identifying and implementing effective knowledge transfer strategies, educational initiatives, and communication plans for Oracle employees and customers. Active participation in industry organizations is essential to remain informed of evolving trends and regulatory developments.
Preferred Qualifications
* 8+ years of relevant experience, preferably working in a healthcare compliance office for a large health system, or consulting on Health IT regulations.
* BA/BS or advanced degree preferred.
* Experience working with Oracle Health Millennium EHR products preferred.
* Must be able to work collaboratively across many different teams on complex regulatory requirements.
* Membership in healthcare trade associations and industry groups preferred.
* Excellent written and verbal communication skills.
* Ability to adjust and adapt to changing priorities in a dynamic environment.
* Technical acumen and the ability to understand and interpret technical specifications.
Additional Responsibilities
Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes. Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections. May serve as point of contact for interactions with regulatory agencies for defined matters. Support the creation of a comprehensive risk management and/or quality management, and regulatory oversight program, including specifications for product and service design aligned with Oracle Software Security Assurance and Security Architecture, and/or Quality Management systems. Review specifications. Develop training for GBU development, cloud services, services and operations teams on industry regulatory specifications applicable to their products and services. Execute risk assessments and evaluate risks to the business and develop risk mitigation strategies. Identify industry requirements applicable to Oracle GBUs, and work with members of GBU development, cloud services, services and operations teams to incorporate applicable industry regulatory standards, Oracle security and/or quality policies and customer-contractual obligations into GBU processes and standards. Coordinate industry and regulatory certifications, including managing certification vendors (e.g., PCI, HIPAA, HITECH, ISO, SOC2). Build security documentation and collateral for customers and internal users allowing security to be a differentiator in this GBUs. Build management level metrics and reporting for activities that are owned by the Risk Manager. Execute a vendor security and/or quality management program.
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