As a Lead Health Policy Strategist, you will lead our regulatory policy work in the EU and UK with a focus on software as a medical device, European Health Data Space, and EU AI Act as applied to medical devices. You will monitor changes in law and guidance and emerging policy trends; attend trade association meetings; participate in industry events and conferences; draft responses to regulatory requests for comment; and foster relationships with regulatory agencies and other thought leaders. The ideal candidate will be viewed as a thought leader in the industry and is someone who can galvanize support and policy momentum for Oracle's regulatory positions. You will collaborate with the Oracle Health & Life Sciences business units, legal and compliance, and government affairs teams across the globe, but especially in the EU and UK. This role requires an individual who can keep up with the fast-paced environment of software development and an evolving regulatory landscape. For this role we are seeking a health regulatory policy strategist who is collaborative, a creative problem solver, and dedicated to excellence in their work.

About the Business:

Oracle's Healthcare and Life Sciences business is a global leader in industry-specific software and solutions to healthcare providers, payers, pharmaceutical companies, medical device companies, and clinical research organizations. We offer a range of products and services, including AI/ML solutions, cloud-based healthcare platforms, data analytics, electronic health records (EHR), and patient engagement systems. The business aims to help organizations improve patient outcomes, lower costs, and accelerate innovation. By leveraging Oracle's technology and expertise, healthcare and life science organizations can streamline their operations, gain insights from data, and make more informed decisions. Oracle also enables secure and compliant handling of sensitive healthcare data, helping organizations meet regulatory requirements and protect patient privacy. With a focus on digital transformation, Oracle's Healthcare and Life Sciences business empowers the industry to embrace modern technologies and improve overall healthcare delivery.

What You'll Do:

• Develop policy positions and strategy on regulatory topics critical to the success of the Oracle Health and Life Sciences business.
• Attend trade association meetings and play an influential role in those organizations.
• Prepare responses to regulator requests for comments on proposed policies or regulation.
• Maintain a network of relationships that yield insight into policy and regulatory trends.
• Attend conferences and industry events where you can advocate for Oracle positions.
• Write articles and blog posts and engage in speaking events.
• Meet with regulators and other thought leaders in the industry and develop positive working relationships with them.
• 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.

Qualifications:

• BA/BS or advanced degree.
• Legal degree preferred.
• Experience with med tech or the life sciences.
• Experience working at or interacting with regulators and trade associations.
• Ability to perform in a fast-paced and continually evolving business environment.
• Excellent written and verbal communication skills.
• Ability to adjust and adapt to changing priorities in a dynamic environment.

As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.

Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.